Recall Z-2199-2016— Synthes (USA) Products LLC

Name: FDA recall Z-2199-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-31

Class II · Terminated

Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2016-05-31, terminated 2017-02-02. It names one FDA 510(k) clearance: K043310. Product: Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/2001 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.. Reason: DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM standard..

Recalling firm: Synthes (USA) Products LLC
Classification: Class II
Status: Terminated
Initiated: 2016-05-31
Terminated: 2017-02-02
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

Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/2001 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

Reason for recall

DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM standard.

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