NRAC Issue #1705 Addendum October 28, 2008 ------------------------------------------------------------------------------- PRODUCT a) Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 44/38, code D; REF 01.00214.144. The product is component of the Metasul LDH Head System intended for noninflammatory degenerative joint disease. (Hip replacement) RECALL NUMBER # Z-2415-2008 PRODUCT b) Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 46/40, code F; REF 01.00214.146. The product is component of the Metasul LDH Head System intended for noninflammatory degenerative joint disease. (Hip replacement) RECALL NUMBER # Z-2416-2008 PRODUCT c) Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 48/42, code H; REF 01.00214.148. The product is component of the Metasul LDH Head System intended for noninflammatory degenerative joint disease. (Hip replacement) RECALL NUMBER # Z-2417-2008 PRODUCT d) Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 50/44, code J; REF 01.00214.150. The product is component of the Metasul LDH Head System intended for noninflammatory degenerative joint disease. (Hip replacement) RECALL NUMBER # Z-2418-2008 PRODUCT e) Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 52/46, code L; REF 01.00214.152. The product is component of the Metasul LDH Head System intended for noninflammatory degenerative joint disease. (Hip replacement) RECALL NUMBER # Z-2419-2008 PRODUCT f) Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 54/48, code N; REF 01.00214.154. The product is component of the Metasul LDH Head System intended for noninflammatory degenerative joint disease. (Hip replacement) RECALL NUMBER # Z-2420-2008 PRODUCT g) Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 56/50, code P; REF 01.00214.156. The product is component of the Metasul LDH Head System intended for noninflammatory degenerative joint disease. (Hip replacement) RECALL NUMBER # Z-2421-2008 PRODUCT h) Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 58/52, code R; REF 01.00214.158. The product is component of the Metasul LDH Head System intended for noninflammatory degenerative joint disease. (Hip replacement) RECALL NUMBER # Z-2422-2008 PRODUCT i) Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 60/54, code T; REF 01.00214.160. The product is component of the Metasul LDH Head System intended for noninflammatory degenerative joint disease. (Hip replacement) RECALL NUMBER # Z-2423-2008 PRODUCT j) Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 62/56, code V; REF 01.00214.162. The product is component of the Metasul LDH Head System intended for noninflammatory degenerative joint disease. (Hip replacement) RECALL NUMBER # Z-2424-2008 PRODUCT k) Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 64/58, code X; REF 01.00214.164. The product is component of the Metasul LDH Head System intended for noninflammatory degenerative joint disease. (Hip replacement) RECALL NUMBER # Z-2425-2008 PRODUCT l) Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 66/60, code Z; REF 01.00214.166. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement) RECALL NUMBER # Z-2426-2008 CODE All units MANUFACTURER Zimmer Gmbh, Winterthur, Switzerland RECALLED BY Zimmer, Inc., Warsaw, IN QUANTITY 19,014 cups DISTRIBUTION Nationwide REASON Instructions for use/surgical technique instructions are inadequate. -------------------------------------------------------------------------------