V 40 Femoral Head, Sterile, 22 mm; Catalog number 6260-4-122, Catalog number 6260-5-226; Howmedica Osteonics Corp., Stry
FDA device recall Z-1822-2009 · posted 2009-08-18 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Sterilization issue: During post-sterilization inspection of the outer blister packaging of the affected lots, it was determined that the outer blister did not meet the required minimum seal width.
- Action taken
- Urgent Product Recall letters were sent via Federal Express on June 18, 2009 to all Stryker Branches/Agencies, hospital Risk Management, hospital Chief of Orthopaedics and surgeons who may have used the recalled products. The letters stated the issue, potential hazards, and the risk mitigation. Customers may contact Colleen O'Meara at 201-831-5970 with any questions.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LWJ
- Quantity affected
- 13 total, both products.
- Distribution
- Nationwide Distribution
- Date initiated
- 2009-06-18
- Date posted
- 2009-08-18
- Date terminated
- 2012-08-27
- 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 |
|---|---|---|
| 36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) (K022077) | Howmedica Osteonics Corp. | 2002-07-25 |
| HOWMEDICA OSTEONICS FEMORAL HEADS (K993601) | Howmedica Osteonics Corp. | 1999-11-16 |