CLAW PLATE 20mm INTERAXIS CHARLOTTE F&A SYSTEM, REF 40S20020, 1 EACH, Rx ONLY, NON STERILE Orthopedic

FDA device recall Z-2599-2014 · posted 2014-09-08 · Terminated

Recall details

Recalling firm

Wright Medical Technology, Inc.

Reason for recall

Plates manufactured from an incorrect raw material.

Action taken

Wright Medical sent an Urgent Medical Device Recall letter dated July 25, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory for the affected product and immediately quarantine all affected product and return to Wright Medical as soon as possible. For return instructions customers were instructed to contact Customer Service at 800-238-7117. Customers were also asked to complete the attached response form, confirming receipt of the notice and the status of the product(s) on hand and return by fax to 901-867-7401. Customers with questions were instructed to call 901-290-5662. For questions regarding this recall call 800-238-7117.

Root cause

Device Design

Status

Terminated

Product code

HRS

Quantity affected

0

Distribution

Worldwide Distribution - USA (Nationwide) and Internationally to Canada Australia, Great Britain, Germany, Spain, Netherlands, France.

Date initiated

2014-07-30

Date posted

2014-09-08

Date terminated

2018-06-15

Location

Memphis, TN

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