Recalls / —

—#129464

Product

CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 30mm, REF 40240230, 1 EACH, Rx ONLY, NON STERILE Orthopedic

FDA product code

HRS — Plate, Fixation, Bone

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K080295, K113014, K133715

Affected lot / code info

Lot Numbers: 1487670, 1487671, 1487672, 1512149, 1519496, 1523745, 1534796, 1537159, 1539400, 1540714

Why it was recalled

Plates manufactured from an incorrect raw material.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm

Wright Medical Technology, Inc.

Address

1023 Cherry Rd, Memphis, Tennessee 38117-5423

Distribution

Distribution pattern

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

Timeline

Recall initiated

2014-07-30

Posted by FDA

2014-09-08

Terminated

2018-06-15

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #129464. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.