Recall Z-0825-2010 ยท HRS Plate, Fixation, Bone
Synthes USA (HQ), Inc.
Synthes In Situ Bender/Cutter Kit-Wide-Sterile. Catalog Number 530.521S.
| Date | Feb 24, 2010 (initiated Jan 6, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 187 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021458 | SYNTHES IN-SITU BENDER/CUTTER Synthes (Usa), Jul 24, 2002 |