Synthes In Situ Bender/Cutter Kit-Wide-Sterile. Catalog Number 530.521S.
FDA device recall Z-0825-2010 · posted 2010-02-24 · Terminated
Recall details
- Recalling firm
- Synthes USA (HQ), Inc.
- Reason for recall
- There is the potential for the bender/cutter attachment to continue heating after release of the power button. There is potential for patient and/or staff injury if continuous heating is unrecognized.
- Action taken
- An "Urgent: Medical Device Recall" letter dated January 8, 2010 was issued to customers via USPS Certified mail. The letter described the issue and affected product. Customers were notified to cease use of the recalled product, examine inventory and follow instructions for return to the firm as indicated in the recall letter. For questions, please call 1-800-620-7025 x 5452 or 1-610-719-5452 or contact your Synthes CMF Sales Consultant.
- Root cause
- Other
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 187 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2010-01-06
- Date posted
- 2010-02-24
- Date terminated
- 2010-10-06
- Location
- West Chester, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNTHES IN-SITU BENDER/CUTTER (K021458) | Synthes (Usa) | 2002-07-24 |