—#91380

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

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lot numbers: 0495581514, 089669448

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Wright Medical Technology Inc
Address: 5677 Airline Rd, Arlington, Tennessee 38002

Distribution

Distribution pattern: Worldwide: USA and The Netherlands

Timeline

Recall initiated: 2010-04-08
Posted by FDA: 2010-06-07
Terminated: 2011-05-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #91380. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.