Recall Z-0681-2017— Synthes (USA) Products LLC

Name: FDA recall Z-0681-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-01

Class II · Terminated

Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2016-11-01, terminated 2017-06-01. It names one FDA 510(k) clearance: K043310. Product: Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile. Reason: Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm diameter Drill Bit..

Recalling firm: Synthes (USA) Products LLC
Classification: Class II
Status: Terminated
Initiated: 2016-11-01
Terminated: 2017-06-01
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K043310 — SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEMSynthes (Usa)·cleared 2005-01-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.