FDAFDA · Food and drugs·Recall number Z-1457-2014
The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Usage: Used to expose bone for procedures.
Published April 23, 2014 · Recall initiated: February 11, 2014
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 Synthes Hohmann Retractor was mis-etched on the product and package as part number 399.24 instead of part number 399.22.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes, Inc.
- Distributor
- Worldwide Distribution - USA Nationwide Distribution in the states of: TN, MD, NY, IN, NJ, WA, VA,and the country of Canada.
- Lot
- part no. 399.24, lot number T974302
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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