Restoration Hip system Cylindrical Distal Extension. Catalog Numbers 1212-3105, 1212-3115, 1212-3125, and 1212-3195. Siz
FDA device recall Z-0719-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics
- Reason for recall
- The Cylindrical Distal Extensions were incorrectly coded and packaged.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 20
- Distribution
- The 9 units were sent out to 2 US branch/agents and one international distributor.
- Date initiated
- 2004-02-10
- Date posted
- 2004-07-20
- Date terminated
- 2004-06-09
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.