FDAFDA · Food and drugs·Recall number Z-0429-2014
Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.
Published December 11, 2013 · Recall initiated: August 1, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The small extendible Soft Tissue Retractor was recalled due to locking nut (clamping sleeve) malfunction.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes USA HQ, Inc.
- Distributor
- Worldwide Distribution - USA (nationwide) and Internationally to Canada and Mexico.
- Lot
- Part J5957AC (old), and Part J5957F (new)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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