Recalls / —

—#42917

Product

Depuy brand Acclaim Elbow linked ulnar bearing, sterile; catalog # 1722-60-000.

FDA product code

JDB — Prosthesis, Elbow, Semi-Constrained, Cemented

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K992656

Affected lot / code info

All units.

Why it was recalled

The ulnar bearing may damage the implant's polyethylene sleeve such that revision surgery is necessary.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified via letter dated 11/10/05 and asked to return product.

Recalling firm

Firm

Depuy Orthopaedics, Inc.

Address

700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

Distribution pattern

Nationwide, Argentina, Ireland, New Zealand and Spain.

Timeline

Recall initiated

2005-11-08

Posted by FDA

2006-02-16

Terminated

2006-06-16

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #42917. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.