Duration packaging distributed by Stryker Orthopaedics, Limerick, Ireland Stryker Ireland Carrigtwohill Industrial Estat
FDA device recall Z-0931-2012 · posted 2012-01-30 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- As part of Stryker's quality process, a packaging discrepancy was identified in specific lots of Stryker's Duration packaging.
- Action taken
- Stryker sent an Urgent Product Recall notification letter and Product Recall Acknowledgment Form dated September 6, 2011 to all affected consignees via FedEx with return receipt. The letter identifed the product, problems, potential hazard, and instructions on how to handled the affected product. Consignees are instructed to Return the affected product to the attention of Regulatory Compliance, Stryker Orthopaedics. Consignees are advised to completed and fax back the attached Product Recall Acknowledgment Form within 5 days to (201) 831-6069. For questions call (201) 972-2100.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- MEH
- Quantity affected
- 39,483 units
- Distribution
- Nationwide Distribution (USA)
- Date initiated
- 2011-09-06
- Date posted
- 2012-01-30
- Date terminated
- 2015-11-17
- 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 |
|---|---|---|
| ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS (K112556) | Howmedica Osteonics Corp. | 2011-09-28 |