—#78771

Product

Biomet Offset Tibial Tray Adaptor, 5.0 MM, sterile, Biomet Orthopedics, Inc., Warsaw, IN, REF 141491. The Biomet Offset Tibial Tray Adaptor is a knee prosthesis intended for cemented use in patients with the following indications: painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved, correction of valgus, varus or posttraumatic deformity, correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

FDA product code: JDW — Pin, Fixation, Threaded
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K010212
Affected lot / code info: Lot 644290.

Why it was recalled

A 2.5mm locking insert was packaged with the 5.0mm Offset Tibial Tray Adaptor instead of the 5.0mm locking insert.

Root cause (FDA determination)

Packaging process control

Action the firm took

Consignees were notified by "Field Safety Corrective Action" letter dated February 13, 2009 to conduct a recall to the hospital level and to locate and return the recalled product to Biomet Orthopedics. Customers were also instructed to complete the enclosed "Fax Back Response Form" and return it via fax to Biomet Orthopedics at 1-574-372-1683. Direct questions about this recall to 1-800-348-9500 or 1-574-372-3983, Monday through Friday, 8 a.m. to 5 p.m.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution including Germany, Italy, Netherlands, Spain and the United Kingdom.

Timeline

Recall initiated: 2009-02-13
Posted by FDA: 2009-04-07
Terminated: 2009-08-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #78771. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.