RecallRadar

FDA Device recall Z-2087-2014

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

On 2014-07-30 the FDA classified a Class II recall of Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System) by Synthes, citing 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 l….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2087-2014
ClassificationClass II
Statusterminated
Initiated2014-05-29
Published2014-07-30
Last updated2026-09-13 11:53 UTC
CompanySynthes
DistributionUS

Product

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

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.

Identifiers

code_infopart no. 03.111.600, lot no. 10-5147, and part no. 03.111.601, lot no. 10-5147

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2087-2014%22

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