Z-0676-2012

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

Name: Z-0676-2012 Synthes Drill Bit for 5.0mm Recon Screws with Large Quick Coupling. This orthopedic manual surgical...
Creator: Synthes USA (HQ), Inc.
Published: 2011-11-02
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2011-11-02 / Terminated / root cause: design

FDA source

Synthes USA (HQ), Inc. began a recall of 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... on 2011-11-02. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0676-2012
Status: Terminated
Initiated: 2011-11-02
Posted: 2012-01-11
Terminated: 2015-04-16
Recalling firm: Synthes GmbH
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.
Product code: HTW Bit, Drill
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.
Root cause tag: design
FDA root cause: Component design/selection
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.
Quantity in commerce: 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, and WY. GOVERNMENT account is Audie Murphy VA Hospital, Chief Supply Svc Whse #1, 7400 Merton Minter Blvd, San Antonio, TX 78229.
Product codes and lots: Drill Bit for 5.0mm Recon Screws/Large QC, model number 03.010.228, all lot numbers.

Product code HTW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)