Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
FDA device recall Z-0010-2007 · posted 2006-10-03 · Terminated
Recall details
- Recalling firm
- Smith & Nephew Inc
- Reason for recall
- Tibial punches were not manufactured to specification and could break at the tip during use.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 4800 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
- Date initiated
- 2006-08-29
- Date posted
- 2006-10-03
- Date terminated
- 2010-04-12
- Location
- Memphis, TN
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