| Class 2 Device Recall Genesis II Oversized Nonporous FinStem Tibial Punch | |
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
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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/ Manufacturer |
Smith & Nephew Inc 1450 E Brooks Rd Memphis TN 38116-1804
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For Additional Information Contact | Victor Rocha 901-399-6771 |
Manufacturer Reason for Recall | Tibial punches were not manufactured to specification and could break at the tip during use. |
FDA Determined Cause 2 | Other |
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 |
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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.
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