Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument.
This recall has been terminated (originally issued July 21, 2014).
- Company
- Synthes, Inc.
- Recall Initiated
- May 29, 2014
- Posted
- July 21, 2014
- Terminated
- August 18, 2016
- Recall Number
- Z-2087-2014
- Quantity
- 180
- Firm Location
- West Chester, PA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Distribution US Nationwide and Bermuda.
Lot / Code Info
part no. 03.111.600, lot no. 10-5147, and part no. 03.111.601, lot no. 10-5147
Root Cause
Process control
Action Taken
An urgent field correction notification, dated May 29, 2014, was sent to end users and sales consultants which described the product, problem, and actions to be taken.
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