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 Recall Z-0676-2012 · Posted 2012-01-11
Recalling FirmSynthes USA (HQ), Inc.
Recall StatusTerminated
Product CodeHTW
Date Initiated2011-11-02
Date Terminated2015-04-16
Product Quantity577
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.
Firm Action
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
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.