Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrume
FDA device recall Z-2087-2014 · posted 2014-07-21 · Terminated
Recall details
- Recalling firm
- Synthes, Inc.
- 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.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 180
- Distribution
- Distribution US Nationwide and Bermuda.
- Date initiated
- 2014-05-29
- Date posted
- 2014-07-21
- Date terminated
- 2016-08-18
- Location
- West Chester, PA
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