Restoration #8 HA Hip Stem, Catalog No. 6013-1216 and Restoration #8 HA Hip Stem, Catalog No. 6013-1218.
FDA device recall Z-0467-03 · posted 2003-01-28 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics
- Reason for recall
- Product mix-up. 16mm stem in a 18mm package.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MEH
- Quantity affected
- 6
- 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 cust
- Date initiated
- 2002-12-02
- Date posted
- 2003-01-28
- Date terminated
- 2003-08-01
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES (K944836) | Osteonics Corp. | 1995-04-10 |