—#91214

Product

DePuy ASR 100 Acetabular Implant, 44 mm, 999800744, sterile, DePuy International, Ltd, Leeds, United Kingdom.

FDA product code: KWA — Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Device class: Class 3
Medical specialty: Orthopedic
510(k) numbers: K080991
Affected lot / code info: 1935006, 1958057, 1958058, 1958059, 1958060, 1958061, 1958062, 1960337, 1960338, 1960339, 1960340, 1960341, 1960342, 2094451, 2094452, 2094469, 2140480, 2140481, 2140482, 2140483, 2155841, 2155842, 2155843, 2155844, 2156082, 2156083, 2172335, 2172336, 2172337, 2172338, 2172339, 2178246, 2178247, 2178248, 2178249, 2178251, 2179277, 2179278, 2179279, 2179282, 2205782, 2205783, 2205784, 2205785, 2205786, 2324941, 2459084, 2467248, 2467249, 2591200, 2609946, 2609947 and Y28HV1000.

Why it was recalled

Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. As part of the post-m

Root cause (FDA determination)

Other

Action the firm took

DePuy Orthopaedics issued a Field Safety Notice to share the new data with surgeons and to reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorshop. For additional information regarding this matter, please contact the DePuy Scientific Information Office at 888 554 2482.

Recalling firm

Firm: Depuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2010-03-05
Posted by FDA: 2010-07-17
Terminated: 2012-05-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #91214. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.