Synthes Drill Bit for 5.0mm Recon Screws with Large Quick Coupling. This orthopedic manual surgical instrument is a non

FDA device recall Z-0676-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Synthes USA (HQ), Inc.

Reason for recall

Synthes is initiating a recall of the Drill Bit for 5.0mm Recon Screws with large Quick Coupling due to the potential for the drill stop to slip on the drill bit.

Action taken

On November 2, 2011 the firm sent "Notice: Medical Device Recall" letters to all consignees, with return receipt request. The letter requested consignees cease use of the device and remove the product from inventory. For questions, call 610-719-5450 or contact your sales consultant.

Root cause

Component design/selection

Status

Terminated

Product code

HTW

Quantity affected

577

Distribution

Product was distributed nationwide to AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, ME, MD, MI, MN, MT, LA, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TX, UT, VA, WA, WV, WI, an

Date initiated

2011-11-02

Date posted

2012-01-11

Date terminated

2015-04-16

Location

West Chester, PA