FDAFDA · Food and drugs·Recall number Z-2087-2014
Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument.
Published July 30, 2014 · Recall initiated: May 29, 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 Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System) were found to be labeled incorrectly. Part no. 03.111.600 (Right) was found in the package labeled part no. 03.111.601 (Left). The laser etching denoting the orientation on the part is correct.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes, Inc.
- Distributor
- Distribution US Nationwide and Bermuda.
- Lot
- part no. 03.111.600, lot no. 10-5147, and part no. 03.111.601, lot no. 10-5147
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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