VariAx Compression Plating System
FDA device recall Z-1507-2016 · posted 2016-04-18 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Stryker received two reports indicating that during screw insertion under a high lateral angle a bone screw went through a oblong hole.
- Action taken
- Stryker Orthopaedics sent notification letters/product accountability forms on October 10, 2013, via email. Customers are provided the product issue, hazards and risk mitigation along with actions needed. Customers should receive the affected products and complete the BRF and return to Stryker. Questions can be directed to Stryker. For further questions, please call (201) 831-5000.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 118 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2013-10-10
- Date posted
- 2016-04-18
- Date terminated
- 2016-04-21
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VARIAX 2 COMPRESSION PLATING SYSTEM (K130009) | Stryker Trauma AG | 2013-03-22 |