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.
FDA Recall Z-1248-2009 · Posted 2009-06-01
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Recalling FirmSynthes Spine
Recall StatusTerminated
Product CodeHRS
Date Initiated2008-12-18
Date Terminated2009-12-15
Product Quantity26 units
Reason for Recall
The bender is heating prior to activation of the power button, requiring disassembly to stop heating.
Firm 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.
Root Cause
Process control
Distribution Pattern
Nationwide distribution: AL, CA, KS, LA, MD, NJ, NV, NY, OR, PA, TX, and UT
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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