RAYHACK DRILL GUIDE ANGLED, REF 4010-0206, 1 EACH, Rx ONLY, NON-STERILE, Wright Medical EMEA Krijgsman 11, 1186 Amstelve

FDA device recall Z-1779-2010 · posted 2010-06-07 · Terminated

Recall details

Recalling firm

Wright Medical Technology Inc

Reason for recall

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

Action taken

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

Status

Terminated

Product code

LXH

Quantity affected

13 units

Distribution

Worldwide: USA and The Netherlands

Date initiated

2010-04-08

Date posted

2010-06-07

Date terminated

2011-05-17

Location

Arlington, TN