Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1779-2010

RAYHACK DRILL GUIDE ANGLED, REF 4010-0206, 1 EACH, Rx ONLY, NON-STERILE, Wright Medical EMEA Krijgsman 11...

Wright Medical Technology Inc / initiated 2010-04-08 / Terminated

Wright Medical Technology Inc began a recall of RAYHACK DRILL GUIDE ANGLED, REF 4010-0206, 1 EACH, Rx ONLY, NON-STERILE, Wright Medical EMEA Krijgsman 11, 1186 Amstelveen, The Netherlands, Wright Medical... on . The reason FDA records is "Drill guides from 2 lots may not seat properly on the compression block". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1779-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Wright Medical Technology Inc
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
Product code
LXH Orthopedic Manual Surgical Instrument
Reason for recall
Drill guides from 2 lots may not seat properly on the compression block.
FDA root cause
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
Product codes and lots
Lot numbers: 0495581514, 089669448