Synthes InSitu Bender Cutter Kit Wide Sterile Catalog number 530.521S, used with Synthes Rapid Resorbable Fixation System for craniofacial skeleton fracture repair and reconstructive procedures.
This recall has been terminated (originally issued June 1, 2009).
- Company
- Synthes Spine
- Recall Initiated
- December 18, 2008
- Posted
- June 1, 2009
- Terminated
- December 15, 2009
- Recall Number
- Z-1248-2009
- Quantity
- 26 units
- Firm Location
- West Chester, PA
- Official Source
- View on FDA website ↗
Reason for Recall
The bender is heating prior to activation of the power button, requiring disassembly to stop heating.
Distribution
Nationwide distribution: AL, CA, KS, LA, MD, NJ, NV, NY, OR, PA, TX, and UT
Lot / Code Info
Catalog number 530.521S - Lot number TM00322 exp 4/13/11
Root Cause
Process control
Action Taken
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.
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