FDA Device

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.

Hazard

The bender is heating prior to activation of the power button, requiring disassembly to stop heating.

What You Should Do

Remedy

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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Products

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.
Brand
Synthes Spine
UPC
Catalog number 530.521S - Lot number TM00322 exp 4/13/11

Units Affected

26 units

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