Restoration #8 HA Hip Stem, Catalog No. 6013-1216 and Restoration #8 HA Hip Stem, Catalog No. 6013-1218.
This recall has been terminated (originally issued January 28, 2003).
- Company
- Stryker Howmedica Osteonics
- Recall Initiated
- December 2, 2002
- Posted
- January 28, 2003
- Terminated
- August 1, 2003
- Recall Number
- Z-0467-03
- Quantity
- 6
- Firm Location
- Mahwah, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Product mix-up. 16mm stem in a 18mm package.
Distribution
The product was shipped to 2 Howmedica branches, 1 hospital, one government hospital, and 2 international distributors. Government hospital is the VA Medical Center, Tampa, FL.. Two international customers are Stryker Howmedica affiliates in Chile and Spain.
Lot / Code Info
Catalog No. 6013-1216 -- Lot Code: 37778302; Catalog No. 6013-1218 -- Lot Code: 37778401.
Root Cause
Other
Action Taken
Branches and agents were notified via letter on 12/2/2002. Hospitals were notified on 12/2/2002 via FedEx to OR Supervisors.
More recalls by Stryker Howmedica Osteonics
Restoration Hip system Cylindrical Distal Extension. Catalog Numbers 1212-3105, 1212-3115, 1212-312...
Jul 20, 2004