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U.S. Department of Health and Human Services

Class 2 Device Recall RAYHACK DRILL GUIDE ANGLED

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  Class 2 Device Recall RAYHACK DRILL GUIDE ANGLED see related information
Date Initiated by Firm April 08, 2010
Date Posted June 07, 2010
Recall Status1 Terminated 3 on May 17, 2011
Recall Number Z-1779-2010
Recall Event ID 55637
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product RAYHACK DRILL GUIDE ANGLED, REF 4010-0206, 1 EACH, Rx ONLY, NON-STERILE, Wright Medical EMEA Krijgsman 11, 1186 Amstelveen, The Netherlands, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002

Intended use: Preparation of the Radius prior to device implantation
Code Information Lot numbers: 0495581514, 089669448
Recalling Firm/
Manufacturer		 Wright Medical Technology Inc
5677 Airline Rd
Arlington TN 38002
For Additional Information Contact Debbie Daurer
901-867-4601
Manufacturer Reason
for Recall		 Drill guides from 2 lots may not seat properly on the compression block.
FDA Determined
Cause 2		 Other
Action The firm, Wright Medical Technology, Inc., sent an "URGENT: Medical Device Voluntary Recall Letter" on April 8, 2010 via FedEx to customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to please examine their inventory of the products and check it against the information provided, and to immediately return any affected products to Wright as soon as possible. The customers were also instructed to contact Customer service at 800-238-7117 for return instructions and replacement inventory. In addition, the customers were to immediately complete and return by fax at 901-867-7401 the attached response confirming receipt of the notice. If you have any questions regarding this matter, please contact Debby Daurer at 800-874-5630.
Quantity in Commerce 13 units
Distribution Worldwide: USA and The Netherlands
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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