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Recall Observatory FDA recall evidence

Device product

Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument.

Z-2087-2014

May 29, 2014

Class II

Product summary

Firm
Synthes, Inc.
Event
Event 68442
Status
Terminated
Classification
Class II
Quantity
180
Official record key
device-enforcement:Z-2087-2014

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.