Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
This recall has been terminated (originally issued October 3, 2006).
- Company
- Smith & Nephew Inc
- Recall Initiated
- August 29, 2006
- Posted
- October 3, 2006
- Terminated
- April 12, 2010
- Recall Number
- Z-0010-2007
- Quantity
- 4800 units
- Firm Location
- Memphis, TN
- Official Source
- View on FDA website ↗
Reason for Recall
Tibial punches were not manufactured to specification and could break at the tip during use.
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.
Lot / Code Info
Catalog Number 71440480 Lot Numbers: All lots prior to 06MM***** Sequence, including those items with suffixes. Catalog Numbers 71440482 Lot Numbers: All lots prior to 06MM***** Sequence, including those items with suffixes. Catalog Number 71440484 Lot Numbers: All lots prior to 06MM***** Sequence, including those items with suffixes. Catalog Number 71440486 Lot Numbers: All lots prior to 06MM***** Sequence, including those items with suffixes.
Root Cause
Other
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.