Recall Z-1249-2009 ยท HRS Plate, Fixation, Bone
Synthes Spine
Synthes InSitu Bender Cutter Kit Narrow Sterile Catalog number 530.522S, used with Synthes Rapid Resorbable Fixation System for craniofacial skeleton fracture repair and reconstructive procedures.
| Date | Jun 1, 2009 (initiated Dec 18, 2008) |
| Status | Terminated |
| Reason | The bender is heating prior to activation of the power button, requiring disassembly to stop heating. |
| Root cause | Process control |
| Action | All affected Synthes CMF Sales Consultants were notified of the Medical Device Recall by phone on 12/19/08 and by letter sent via return receipt email on 12/22/08. All affected hospitals were notified by letter mailed on 12/22/08 via USPS certified mail. |
| Quantity | 40 units |
| Distribution | Nationwide distribution: AL, CA, KS, LA, MD, NJ, NV, NY, OR, PA, TX, and UT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021458 | SYNTHES IN-SITU BENDER/CUTTER Synthes (Usa), Jul 24, 2002 |