Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument.
FDA Recall Z-2087-2014 · Posted 2014-07-21
Recalling FirmSynthes, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2014-05-29
Date Terminated2016-08-18
Product Quantity180
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.
Firm Action
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
Distribution Pattern
Distribution US Nationwide and Bermuda.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.