Synthes, Inc.: Medical Device Recall in 2014 - (Recall #: Z-2087-2014)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2014.
Data Source: FDA.
Product Description:
Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument.
Product Classification:
Class II
Date Initiated: May 29, 2014
Date Posted: July 30, 2014
Recall Number: Z-2087-2014
Event ID: 68442
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.
Status: Terminated
Product Quantity: 180
Code Information:
part no. 03.111.600, lot no. 10-5147, and part no. 03.111.601, lot no. 10-5147
Distribution Pattern:
Distribution US Nationwide and Bermuda.
Voluntary or Mandated:
Voluntary: Firm initiated