—#114761

Product

Biomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490 Sterile, QTY.1 Product Usage: Knee joint replacement prostheses intended for application with or without bone cement. Knee joint replacement components include femoral, tibial, and patellar components, intended for both primary and revision applications. Indications: 1) painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis when one or more compartments are involved, 2) correction of varus, valgus, or posttraumatic deformity, 3) correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure

FDA product code: MBV — Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K010212
Affected lot / code info: Catalog Number: 141490 Lot 378330,378320,407230,485010,505140,485000,506070,533400,54048, 439700,797820

Why it was recalled

Biomet investigation identified that the square end of the offset tibial tray adaptor locking insert is oversized and may not engage insert tool screwdriver. This could cause a possible delay in surgery greater than 30 minutes, potentially exposing the patient to the increased risks from being under anesthesia for a longer duration.

Root cause (FDA determination)

Employee error

Action the firm took

Biomet Recall sent an Urgent Medical Device Recall Notices letter dated November 15, 2012 to distributors, hospital operating room(OR)managers and Surgeons receiving the affected product. The letter identified the affected product, the reason for the recall and actions to be take, including directions to immediately locate and discontinue use of the affected product. Customers were asked to confirm receipt of the notice by calling 1-888-348-9500 extension 1570. Customers with affected product to be returned are asked to obtain RGA # by calling 574-372-6677 or email: rgarequest@biomet.com. A FAX Back Response Form is to be filled out and sent within 3 days of receipt to 574-372-1683. Return product to the Attention of Audrey Daenzer, Field Action Coordinator, Biomet, Attention Return Goods, Building B Recalls, 56 East Bell Drive, Warsaw, IN 46580. Questions related to the notice should be directed to 474-372-3983 or 574-371-3009, Monday- Friday 8 a.m. to 5 p.m.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: Worldwide distribution - USA (nationwide) and the countries of Australia, Canada, Chile, Europe, Japan, Korea, Panama, Puerto Rico and Thailand.

Timeline

Recall initiated: 2012-11-15
Posted by FDA: 2012-12-17
Terminated: 2013-11-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #114761. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.