NRAC Issue #1675 ADDENDUM March 25, 2008 NATIONAL RECALL ALERT CENTER - IMMEDIATE WARNING ALERT NOTIFICATION THE FOLLOWING HAVE BEEN RECALLED OR ARE SUBJECT TO FIELD CORRECTION THIS LISTING IS ISSUED BY - NATIONAL RECALL ALERT CENTER, WASHINGTON, D.C. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT 1) Stryker Orthopedics, UHR Universal Bipolar Component; 26 x 42 mm, Hip Prosthesis Component RECALL NUMBER # Z-0621-2008 PRODUCT 2) Stryker Orthopedics UHR Universal Bipolar Component; 26 x 44 mm, Hip Prosthesis Component RECALL NUMBER # Z-0622-2008 PRODUCT 3) Stryker Orthopedics; UHR Universal Bipolar Component; 28 x 44 mm, Hip Prosthesis Component RECALL NUMBER # Z-0623-2008 PRODUCT 4) Stryker Orthopedics; UHR Universal Bipolar Component; 26 x 45 mm, Hip Prosthesis Component RECALL NUMBER # Z-0624-2008 PRODUCT 5) Stryker Orthopedics; UHR Universal Bipolar Component; 28 x 45 mm, Hip Prosthesis Component RECALL NUMBER # Z-0625-2008 PRODUCT 6) Stryker Orthopedics; UHR Universal Bipolar Component; 26 x 46 mm, Hip Prosthesis Component RECALL NUMBER # Z-0626-2008 PRODUCT 7) Stryker Orthopedics; UHR Universal Bipolar Component; 28 x 46 mm, Hip Prosthesis Component RECALL NUMBER # Z-0627-2008 PRODUCT 8) Stryker Orthopedics; UHR Universal Bipolar Component; 26 x 43 mm, Hip Prosthesis Component RECALL NUMBER # Z-0628-2008 PRODUCT 9) Stryker Orthopedics; UHR Universal Bipolar Component; 26 x 47 mm, Hip Prosthesis Component RECALL NUMBER # Z-0629-2008 PRODUCT 10) Stryker Orthopedics; UHR Universal Bipolar Component; 28 x 47 mm, Hip Prosthesis Component RECALL NUMBER # Z-0630-2008 PRODUCT 11) Stryker Orthopedics; UHR Universal Bipolar Component; 26 x 48 mm, Hip Prosthesis Component RECALL NUMBER # Z-0631-2008 PRODUCT 12) Stryker Orthopedics; UHR Universal Bipolar Component; 28 x 48 mm, Hip Prosthesis Component RECALL NUMBER # Z-0632-2008 PRODUCT 13) Stryker Orthopedics; UHR Universal Bipolar Component; 26 x 49 mm, Hip Prosthesis Component RECALL NUMBER # Z-0633-2008 PRODUCT 14) Stryker Orthopedics; UHR Universal Bipolar Component; 28 x 49 mm, Hip Prosthesis Component RECALL NUMBER # Z-0634-2008 PRODUCT 15) Stryker Orthopedics; UHR Universal Bipolar Component; 26 x 50 mm, Hip Prosthesis Component RECALL NUMBER # Z-0635-2008 PRODUCT 16) Stryker Orthopedics; UHR Universal Bipolar Component; 28 x 50 mm, Hip Prosthesis Component RECALL NUMBER # Z-0636-2008 PRODUCT 17) Stryker Orthopedics; UHR Universal Bipolar Component; 28 x 51 mm, Hip Prosthesis Component RECALL NUMBER # Z-0637-2008 PRODUCT 18) Stryker Orthopedics; UHR Universal Bipolar Component; 26 x 51 mm, Hip Prosthesis Component RECALL NUMBER # Z-0638-2008 PRODUCT 19) Stryker Orthopedics; UHR Universal Bipolar Component; 26 x 52 mm, Hip Prosthesis Component RECALL NUMBER # Z-0639-2008 PRODUCT 20) Stryker Orthopedics; UHR Universal Bipolar Component; 26 x 53 mm, Hip Prosthesis Component RECALL NUMBER # Z-0640-2008 PRODUCT 21) Stryker Orthopedics; UHR Universal Bipolar Component; 28 x 52 mm, Hip Prosthesis Component RECALL NUMBER # Z-0641-2008 PRODUCT 22) Stryker Orthopedics; UHR Universal Bipolar Component; 28 x 53 mm, Hip Prosthesis Component RECALL NUMBER # Z-0642-2008 PRODUCT 23) Stryker Orthopedics; UHR Universal Bipolar Component; 26 x 54 mm, Hip Prosthesis Component RECALL NUMBER # Z-0643-2008 PRODUCT 24) Stryker Orthopedics; UHR Universal Bipolar Component; 26 x 55 mm, Hip Prosthesis Component RECALL NUMBER # Z-0644-2008 PRODUCT 25) Stryker Orthopedics; UHR Universal Bipolar Component; 28 x 55 mm, Hip Prosthesis Component RECALL NUMBER # Z-0645-2008 PRODUCT 26) Stryker Orthopedics; UHR Universal Bipolar Component; 28 x 56 mm, Hip Prosthesis Component RECALL NUMBER # Z-0646-2008 PRODUCT 27) Stryker Orthopedics; UHR Universal Bipolar Component; 26 x 41 mm, Hip Prosthesis Component RECALL NUMBER # Z-0647-2008 PRODUCT 28) Stryker Orthopedics; UHR Universal Bipolar Component; 28 x 54 mm, Hip Prosthesis Component RECALL NUMBER # Z-0648-2008 PRODUCT 29) Stryker Orthopedics; UHR Universal Bipolar Component; 28 x 56 mm, Hip Prosthesis Component RECALL NUMBER # Z-0649-2008 PRODUCT 30) Stryker Orthopedics; UHR Universal Bipolar Component; 26 x 56 mm, Hip Prosthesis Component RECALL NUMBER # Z-0650-2008 PRODUCT 31) Stryker Orthopedics; UHR Universal Bipolar Component; 28 x 58 mm, Hip Prosthesis Component RECALL NUMBER # Z-0651-2008 PRODUCT 32) Stryker Orthopedics; UHR Universal Bipolar Component; 26 x 61 mm, Hip Prosthesis Component RECALL NUMBER # Z-0652-2008 PRODUCT 33) Stryker Orthopedics; UHR Universal Bipolar Component; 28 x 61 mm, Hip Prosthesis Component RECALL NUMBER # Z-0653-2008 PRODUCT 34) Stryker Orthopedics; UHR Universal Bipolar Component; 26 x 68 mm, Hip Prosthesis Component RECALL NUMBER # Z-0654-2008 PRODUCT 35) Stryker Orthopedics; UHR Universal Bipolar Component; 28 x 68 mm, Hip Prosthesis Component RECALL NUMBER # Z-0655-2008 PRODUCT 36) Stryker Orthopedics; UHR Universal Bipolar Component; 28 x 72 mm, Hip Prosthesis Component RECALL NUMBER # Z-0656-2008 CODE 1) Ref No: Description: Lot Code: UH1-42-26 UHR BIPOLAR 26X42mm HD8MJA UH1-42-26 K53MND UH1-42-26 TK6MEA 2) Ref No: Description: Lot Code: UH1-44-26 UHR BIPOLAR 26X44mm 5NDMLA UH1-44-26 UHR BIPOLAR 26X44mm 5NEMLA UH1-44-26 UHR BIPOLAR 26X44mm 7PDMCA UH1-44-26 UHR BIPOLAR 26X44mm PEKMEA UH1-44-28 UHR BIPOLAR 26X44mm 2RKMED UH1-44-26 29AMPD UH1-44-26 4JDMPD UH1-44-26 4JEMPD UH1-44-26 DT9MND UH1-44-26 M15MHD 3) Ref No: Description: Lot Code: UH1-44-28 UHR BIPOLAR 28X44mm 3K4MMD UH1-44-28 UHR BIPOLAR 28X44mm 5P0MLA UH1-44-28 UHR BIPOLAR 28X44mm JEMMNA UH1-44-28 04YMPD UH1-44-28 0YHMMD UH1-44-28 247MMD UH1-44-28 29EMPD UH1-44-28 2HYMRA UH1-44-28 66NMKD UH1-44-28 6W5MPD UH1-44-28 6W6MPD UH1-44-28 8XEMPD UH1-44-28 8XKMPD UH1-44-28 9W0MJA UH1-44-28 D05MKD UH1-44-28 ED8MND UH1-44-28 EP2MPA UH1-44-28 K57MND UH1-44-28 K6LMND UH1-44-28 LA6MPA UH1-44-28 V13MLD UH1-44-28 V17MLD 4) Ref No: Description: Lot Code: UH1-45-26 UHR BIPOLAR 26X45mm 2RJMPA UH1-45-26 UHR BIPOLAR 26X45mm 2RMMPA UH1-45-26 UHR BIPOLAR 26X45mm K15MPA UH1-45-26 3KDMMD UH1-45-26 3KLMPD UH1-45-26 4JHMPD UH1-45-26 637MKD UH1-45-26 75TMMD UH1-45-26 E94MPD UH1-45-26 EDAMND UH1-45-26 EDDMND UH1-45-26 K4VMND 5) Ref No: Description: Lot Code: UH1-45-28 UHR BIPOLAR 28X45mm 6AWMNA UH1-45-28 UHR BIPOLAR 28X45mm 88LMNA UH1-45-28 UHR BIPOLAR 28X45mm V1RMLD UH1-45-28 0YMMMD UH1-45-28 3KKMMD UH1-45-28 4JJMPD UH1-45-28 6W7MPD UH1-45-28 8XLMPD UH1-45-28 DTEMND UH1-45-28 EHRMKA UH1-45-28 L96MPA UH1-45-28 PM5MEA UH1-45-28 PM7MEA UH1-45-28 V1LMLD UH1-45-28 V1MMLD UH1-45-28 V1NMLD UH1-45-28 V1TMLD 6) Ref No: Description: Lot Code: UH1-46-26 UHR BIPOLAR 26X46mm 0A4MLA UH1-46-26 UHR BIPOLAR 26X46mm 88WMNA UH1-46-26 UHR BIPOLAR 26X46mm D4KMDD UH1-46-26 UHR BIPOLAR 26X46mm D7YMKA UH1-46-26 7YYMPD UH1-46-26 8P4MLD UH1-46-26 JD0MND 7) Ref No: Description: Lot Code: UH1-46-28 UHR BIPOLAR 28X46mm 155MJA UH1-46-28 UHR BIPOLAR 28X46mm 1V9MED UH1-46-28 UHR BIPOLAR 28X46mm 615MMD UH1-46-28 UHR BIPOLAR 28X46mm 9PMMMA UH1-46-28 UHR BIPOLAR 28X46mm T55MEA UH1-46-28 0YJMMD UH1-46-28 248MMD UH1-46-28 29JMPD UH1-46-28 3K2MMD UH1-46-28 4DLMMD UH1-46-28 800MPD UH1-46-28 8XMMPD UH1-46-28 E98MPD UH1-46-28 LAPMPA UH1-46-28 LARMPA UH1-46-28 N8WMPA UH1-46-28 N93MPA UH1-46-28 N94MPA 8) Ref No: Description: Lot Code: UH1-43-26 UHR BIPOLAR 26X43mm 341MCA UH1-43-26 UHR BIPOLAR 26X43mm 4DEMMD UH1-43-26 UHR BIPOLAR 26X43mm J9YMAD UH1-43-26 UHR BIPOLAR 26X43mm KP6MJD UH1-43-26 1DYMPD UH1-43-26 3KHMPD UH1-43-26 ED7MND 9) Ref No: Description: Lot Code: UH1-47-26 UHR BIPOLAR 26X47mm 0A8MMA UH1-47-26 UHR BIPOLAR 26X47mm K1AMHA UH1-47-26 801MPD UH1-47-26 K1AMHA 10) Ref No: Description: Lot Code: UH1-47-28 UHR BIPOLAR 28X47mm 87YMCA UH1-47-28 2J3MHA UH1-47-28 6W8MPD UH1-47-28 K5HMND UH1-47-28 L94MPA UHI -47-28 057MPD 11) Ref No: Description: Lot Code: UH1-48-26 UHR BIPOLAR 26X48mm ELYMLA UH1-48-26 UHR BIPOLAR 26X48mm LXWMHD UH1-48-26 802MPD UH1-48-26 E99MPD UH1-48-26 RDRMEA UH1-48-26 RDVMEA 12) Ref No: Description: Lot Code: UH1-48-28 UHR BIPOLAR 28X48mm 0YNMMD UH1-48-28 UHR BIPOLAR 28X48mm 1A7MEA UH1-48-28 UHR BIPOLAR 28X48mm 611MMD UH1-48-28 UHR BIPOLAR 28X48mm EYRMLD UH1-48-28 UHR BIPOLAR 28X48mm MALMDA UH1-48-28 1A7MEA UH1-48-28 62JMKD UH1-48-28 803MPD UH1-48-28 A24MND 13) Ref No: Description: Lot Code: UH1-49-26 UHR BIPOLAR 26X49mm 0N3MJD UH1-49-26 UHR BIPOLAR 26X49mm K22MHA UH1-49-26 804MPD UH1-49-26 D10MKD 14) Ref No: Description: Lot Code: UH1-49-28 UHR BIPOLAR 28X49mm 63PMDD UH1-49-28 4JNMPD UH1-49-28 D78MKA UH1-49-28 K51MND UH1-49-28 KHRMEA UH1-49-28 KHTMEA UH1-49-28 KHWMEA UH1-49-28 MHLMKD 15) Ref No: Description: Lot Code: UH1-50-26 UHR BIPOLAR 26X50mm 6X5MAD UH1-50-26 UHR BIPOLAR 26X50mm J3VMKA UH1-50-26 UHR BIPOLAR 26X50mm J84MDA UH1-50-26 KJ1MEA UH1-50-26 KJ4MEA UH1-50-26 KJ8MEA UH1-50-26 KJ9MEA UH1-50-26 KJAMEA; 16) Ref No: Description: Lot Code: UH1-50-28 UHR BIPOLAR 28X50mm 0L7MHD UH1-50-28 UHR BIPOLAR 28X50mm 3JDMKA UH1-50-28 UHR BIPOLAR 28X50mm N4NMRA UH1-50-28 1E6MEA UH1-50-28 1EEMPD UH1-50-28 4E4MMD UH1-50-28 685MTA UH1-50-28 6W9MPD UH1-50-28 805MPD UH1-50-28 8HMMJA UH1-50-28 8XNMPD UH1-50-28 E9EMPD UH1-50-28 EKPMEA UH1-50-28 HHYMDA UH1-50-28 HLEMEA UH1-50-28 K5AMND 17) Ref No: Description: Lot Code: UH1-51-28 UHR BIPOLAR 28X51mm AD0MLA UH1-51-28 UHR BIPOLAR 28X51mm D8XMLD UH1-51-28 0MNMJD UH1-51-28 763MMD UH1-51-28 7DJMND 18) Ref No: Description: Lot Code: UH1-51-26 UHR BIPOLAR 26X51mm 38RMNA UH1-51-26 UHR BIPOLAR 26X51mm 8MXMDD UH1-51-26 D91MPD UH1-51-26 K52MND 19) Ref No: Description: Lot Code: UH1-52-26 UHR BIPOLAR 26X52mm 09NMKA UH1-52-26 UHR BIPOLAR 26X52mm MVHMTA UH1-52-26 3KTMPD UH1-52-26 8XPMPD UH1-52-26 D92MPD UH1-52-26 EDKMND UH1-52-26 K6RMND 20) Ref No: Description: Lot Code: UH1-53-26 UHR BIPOLAR 26X53mm 0N2MJD UH1-53-26 UHR BIPOLAR 26X53mm N40MRA UH1-53-26 UHR BIPOLAR 26X53mm XLJMKD UH1-53-26 0N1MJD UH1-53-26 29NMPD UH1-53-26 806MPD 21) Ref No: Description: Lot Code: UH1-52-28 UHR BIPOLAR 28X52mm 1VKMED UH1-52-28 UHR BIPOLAR 28X52mm 53MMLD UH1-52-28 3KXMPD UH1-52-28 3KYMPD UH1-52-28 4KPMCA UH1-52-28 5JMMPD UH1-52-28 77MMLD UH1-52-28 8XRMPD UH1-52-28 D93MPD UH1-52-28 E9HMPD UH1-52-28 EDLMND UH1-52-28 EDRMND 22) Ref No: Description: Lot Code: UH1-53-28 UHR BIPOLAR 28X53mm 65KMDD UH1-53-28 28601C UH1-53-28 29PMPD UH1-53-28 406MTA UH1-53-28 807MPD 23) Ref No: Description: Lot Code: UH1-54-26 UHR BIPOLAR 26X54mm 8EYMCA UH1-54-26 4JTMPD UH1-54-26 K6VMND 24) Catalog number; description; lot code: UH1-55-26 UHR BIPOLAR 26X55mm REYMKD UH1-55-26 UHR BIPOLAR 26X55mm XAHMAD UH1-55-26 8XWMPD UH1-55-26 W22MEA 25) Catalog Number; description; lot code: UH1-55-28 UHR BIPOLAR 28X55mm 1EHMPD UH1-55-28 UHR BIPOLAR 28X55mm D31MLA 26) Ref No: Description: Lot Code: UH1-56-28 UHR BIPOLAR 28X56mm 8Y1MED UH1-56-28 4JWMPD UH1-56-28 8HRMCA UH1-56-28 8Y0MPD UH1-56-28 8Y1MED UH1-56-28 K5JMND 27) Ref No: Lot Code: UH1-41-26 A7LMKD UH1-41-26 DT8MND 28) Ref No: Lot Code: UH1-54-28 5JNMPD UH1-54-28 EDTMND UH1-54-28 HE2MND UH1-54-28 KX6MKD UH1-54-28 LPYMNA UH1-54-28 NARMKD 29) Ref No: Lot Code: UH1-56-28 4JWMPD UH1-56-28 8HRMCA UH1-56-28 8Y0MPD UH1-56-28 8Y1MED UH1-56-28 K5JMND 30) Ref No: Lot Code: UH1-56-26 4JVMPD UH1-56-26 8XXMPD UH1-56-26 DTPMND 31) Ref No: Lot Code: UH1-58-28 3L0MPD UH1-58-28 3L1MPD UH1-58-28 86TMND UH1-58-28 86VMND 32) Ref No: Lot Code: UH1-61-26 EDWMND 33) Ref No: Lot Number: UH1-61-28 7DVMND UH1-61-28 DTRMND 34) Ref No: Lot Number: UH1-68-26 80AMPD UH1-68-26 A34MPD 35) Ref No: Lot Number: UH1-68-28 MR0MMD 36) Ref No: Lot Number: UH1-72-28 05AMPD MANUFACTURED & RECALLED BY Styker Howmedica Osteonics Corp., Mahwah, NJ QUANTITY 360 units DISTRIBUTION Nationwide and Internationally REASON Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) Smith & Nephew CALAXO Bioabsorbable lnterference Screw, 6 mm x 20 mm, P/N 7211109, Ligament Screw RECALL NUMBER # Z-0593-2008 PRODUCT b) Smith & Nephew CALAXO Bioabsorbable lnterference Screw, 6 mm x 25 mm, P/N 7211110, Ligament Screw RECALL NUMBER # Z-0594-2008 PRODUCT c) Smith & Nephew CALAXO Bioabsorbable lnterference Screw, Reverse Thread, 6 mm x 25 mm, P/N 7211111, Ligament Screw RECALL NUMBER # Z-0595-2008 PRODUCT d) Smith & Nephew CALAXO Bioabsorbable lnterference Screw, 7 mm x 20 mm, P/N 7211112, Ligament Screw RECALL NUMBER # Z-0596-2008 PRODUCT e) Smith & Nephew CALAXO Bioabsorbable lnterference Screw, 7 mm x 25 mm, P/N 7211113, Ligament Screw RECALL NUMBER # Z-0597-2008 PRODUCT f) Smith & Nephew CALAXO Bioabsorbable lnterference Screw, Reverse Thread, 7 mm x 25 mm, P/N 7211114, Ligament Screw RECALL NUMBER # Z-0598-2008 PRODUCT g) Smith & Nephew CALAXO Bioabsorbable lnterference Screw, 7 mm x 30 mm, P/N 7211115, Ligament Screw RECALL NUMBER # Z-0599-2008 PRODUCT h) Smith & Nephew CALAXO Bioabsorbable lnterference Screw, 8 mm x 25 mm, P/N 7211116, Ligament Screw RECALL NUMBER # Z-0600-2008 PRODUCT i) Smith & Nephew CALAXO Bioabsorbable lnterference Screw, 8 mm x 30 mm, P/N 7211117, Ligament Screw RECALL NUMBER # Z-0601-2008 PRODUCT j) Smith & Nephew CALAXO Bioabsorbable lnterference Screw, 8 mm x 35 mm, P/N 7211118, Ligament Screw RECALL NUMBER # Z-0602-2008 PRODUCT k) Smith & Nephew CALAXO Bioabsorbable lnterference Screw, 9 mm x 25 mm, P/N 7211119, Ligament Screw RECALL NUMBER # Z-0603-2008 PRODUCT l) Smith & Nephew CALAXO Bioabsorbable lnterference Screw, 9 mm x 30 mm, P/N 7211120, Ligament Screw RECALL NUMBER # Z-0604-2008 PRODUCT m) Smith & Nephew CALAXO Bioabsorbable lnterference Screw, 9 mm x 35 mm, P/N 7211121, Ligament Screw RECALL NUMBER # Z-0605-2008 PRODUCT n) Smith & Nephew CALAXO Bioabsorbable lnterference Screw, 10 mm x 25 mm, P/N 7211122, Ligament Screw RECALL NUMBER # Z-0606-2008 PRODUCT o) Smith & Nephew CALAXO Bioabsorbable lnterference Screw, 10 mm x 30 mm, P/N 7211123, Ligament Screw RECALL NUMBER # Z-0607-2008 PRODUCT p) Smith & Nephew CALAXO Bioabsorbable lnterference Screw, 10 mm x 35 mm, P/N 7211124, Ligament Screw RECALL NUMBER # Z-0608-2008 PRODUCT q) Smith & Nephew CALAXO Bioabsorbable lnterference Screw, 11 mm x 30 mm, P/N 7211125, Ligament Screw RECALL NUMBER # Z-0609-2008 PRODUCT r) Smith & Nephew CALAXO Bioabsorbable lnterference Screw, 11 mm x 35 mm, P/N 7211126, Ligament Screw RECALL NUMBER # Z-0610-2008 PRODUCT s) Smith & Nephew CALAXO Bioabsorbable lnterference Screw, 12 mm x 35 mm, P/N 7211127, Ligament Screw RECALL NUMBER # Z-0611-2008 PRODUCT t) Smith & Nephew CALAXO Bioabsorbable lnterference Screw, 8 mm x 20 mm, P/N 72201069, Ligament Screw RECALL NUMBER # Z-0612-2008 PRODUCT u) Smith & Nephew CALAXO Bioabsorbable lnterference Screw, 9 mm x 20 mm, P/N 72201070, Ligament Screw RECALL NUMBER # Z-0613-2008 PRODUCT v) Smith & Nephew CALAXO Bioabsorbable lnterference Screw, 10 mm x 20 mm, P/N 72201071, Ligament Screw RECALL NUMBER # Z-0614-2008 PRODUCT w) Smith & Nephew CALAXO Bioabsorbable lnterference Screw, 11 mm x 25 mm, P/N 72201072, Ligament Screw RECALL NUMBER # Z-0615-2008 PRODUCT x) Smith & Nephew CALAXO Bioabsorbable lnterference Screw, Reverse Thread, 8 mm x 25 mm, P/N 72201073, Ligament Screw RECALL NUMBER # Z-0616-2008 CODE All lots MANUFACTURER Smith & Nephew, Inc., Endoscopy Division, Mansfield, MA RECALLED BY Smith & Nephew, Inc., Endoscopy Division, Andover, MA QUANTITY 68,285 units DISTRIBUTION Nationwide and Internationally REASON Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. --------------------------------------------------------------------------- 1