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Terminated

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

FDA Recall Z-1779-2010 · Posted 2010-06-07

Recall StatusTerminated
Product CodeLXH
Date Initiated2010-04-08
Date Terminated2011-05-17
Product Quantity13 units

Reason for Recall

Drill guides from 2 lots may not seat properly on the compression block.

Firm 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.

Root Cause

Other

Distribution Pattern

Worldwide: USA and The Netherlands

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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