Restoration Hip system Cylindrical Distal Extension. Catalog Numbers 1212-3105, 1212-3115, 1212-3125, and 1212-3195. Sizes 12.5mm, 11.5mm, 19.5mm, and 10.5mm extensions.
This recall has been terminated (originally issued July 20, 2004).
- Company
- Stryker Howmedica Osteonics
- Recall Initiated
- February 10, 2004
- Posted
- July 20, 2004
- Terminated
- June 9, 2004
- Recall Number
- Z-0719-04
- Quantity
- 20
- Firm Location
- Mahwah, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
The Cylindrical Distal Extensions were incorrectly coded and packaged.
Distribution
The 9 units were sent out to 2 US branch/agents and one international distributor.
Lot / Code Info
Lots: 96910501; 96949401; 96940901; 96950901.
Root Cause
Other
Action Taken
Stryker Orthopaedics sent product recall letters to the Branch/Agency involved on 2/10/2004 via FedEx. International distributor was sent notification on 2/10/2004.
More recalls by Stryker Howmedica Osteonics
Restoration T3 Revision Hip System, Femoral Hip Prosthesis. Various lengths and Model numbers.
626...
Jul 20, 2004
Trident Insert Impactor
May 29, 2003