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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes drill bit for 5.0mm Recon Screws/Large QC

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  Class 2 Device Recall Synthes drill bit for 5.0mm Recon Screws/Large QC see related information
Date Initiated by Firm November 02, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on April 16, 2015
Recall Number Z-0676-2012
Recall Event ID 60406
Product Classification Bit, drill - Product Code HTW
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.
Code Information Drill Bit for 5.0mm Recon Screws/Large QC, model number 03.010.228, all lot numbers.
Recalling Firm/
Manufacturer		 Synthes USA (HQ), Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Customer Support
610-719-5000
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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