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U.S. Department of Health and Human Services

Class 2 Device Recall Genesis II Oversized Nonporous FinStem Tibial Punch

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  Class 2 Device Recall Genesis II Oversized Nonporous FinStem Tibial Punch see related information
Date Initiated by Firm August 29, 2006
Date Posted October 03, 2006
Recall Status1 Terminated 3 on April 12, 2010
Recall Number Z-0011-2007
Recall Event ID 36293
Product Classification Tibial Punch - Product Code LXH
Product Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Code Information Catalog Number 71927102 (Size 1-2) Lot Numbers 06AM00936, 05KM07017, 04KM18886, 04JM05040, 03FM11332, 03FM11334, 03DM01797, 02FM07372, 02CM04108, 01LM08844, 01AM16024, 00306631  Catalog Number 71927103 (Size 3-4) Lot Numbers: 06AM00937, 04LM11514, 04KM18887, 04KM12225, 04FM08554, 03FM11350, 03FM11352, 03DM01798, 02FM07387, 02CM04110, 01LM08847, 00306632  Catalog Number 71927104 (Size 5-6) Lot Numbers: 04KM15385, 04LM09224, 03FM11353, 03DM01800, 02CM04114, 01LM08850, 00306635  Catalog Number 71927105 (Size 7-8) Lot Numbers: 06AM00940, 05KM07018, 04KM18889, 04LM09225, 04FM08555, 03FM11356, 03FM11355, 03DM01803, 02CM04121, 02CM04118, 01LM08854, 01LM08852, 01HM12256, 01BM14137, 00306638
Recalling Firm/
Smith & Nephew Inc
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact Victor Rocha
Manufacturer Reason
for Recall
Tibial punches were not manufactured to specification and could break at the tip during use.
FDA Determined
Cause 2
Action Recall notification was initiated by letter (Fed Ex) to domestic territory manager and sales representative and to international distributors (via email and telephone follow-up) on 08/29/2006 to request the return of any in stock product.
Quantity in Commerce 62 units
Distribution Worldwide distribution ----- including USA and countries of Austria, Australia, Belgium, Canada, China, Dubai, France, Germany, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Portugal, Singapore, South Africa, South Korea, Spain, Turkey, United Kingdom, and Venezuela.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.