S2 System, Locking Screw Fully Threaded
FDA device recall Z-0167-06 · posted 2005-11-18 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Stryker Orthopaedics was informed by the manufacturer, that in some instances, the sterile blister package of the referenced G/K, T2 condyle and some S2 screw products may become damaged during shipping and handling which may result in a potential breach of the sterile barrier.
- Action taken
- The product recall will extend to all branches.agencies and hospitals that have received the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 2465 units
- Distribution
- nationwide
- Date initiated
- 2005-10-04
- Date posted
- 2005-11-18
- Date terminated
- 2006-05-04
- 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 |
|---|---|---|
| S2 FEMORAL NAIL (K021026) | Howmedica Osteonics Corp. | 2002-04-25 |