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Terminated

Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile

FDA Recall Z-0681-2017 · Posted 2016-12-01

Recalling FirmSynthes (USA) Products LLC
Recall StatusTerminated
Product CodeHWE
Date Initiated2016-11-01
Date Terminated2017-06-01
Product Quantity84 units

Reason for Recall

Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm diameter Drill Bit.

Firm Action

DePuy Synthes sent an Urgent Notice to customers affected by the recall to inform them of the potential impacts, and actions to be taken for the return of the identified units.

Root Cause

Under Investigation by firm

Distribution Pattern

Distributed Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043310SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEMSynthes (Usa) · 2005-01-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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