—#105259

Product

Synthes Drill Bit for 5.0mm Recon Screws with Large Quick Coupling. This orthopedic manual surgical instrument is a non powered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.

FDA product code: HTW — Bit, Drill
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Drill Bit for 5.0mm Recon Screws/Large QC, model number 03.010.228, all lot numbers.

Why it was recalled

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.

Root cause (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Synthes USA (HQ), Inc.
Address: 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

Distribution pattern: 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, and WY. GOVERNMENT account is Audie Murphy VA Hospital, Chief Supply Svc Whse #1, 7400 Merton Minter Blvd, San Antonio, TX 78229.

Timeline

Recall initiated: 2011-11-02
Posted by FDA: 2012-01-11
Terminated: 2015-04-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #105259. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.