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 Recall Z-1061-2009 · Posted 2009-04-07
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Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeJDW
Date Initiated2009-02-13
Date Terminated2009-08-11
Product Quantity17
Reason for Recall
A 2.5mm locking insert was packaged with the 5.0mm Offset Tibial Tray Adaptor instead of the 5.0mm locking insert.
Firm Action
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.
Root Cause
Packaging process control
Distribution Pattern
Worldwide Distribution including Germany, Italy, Netherlands, Spain and the United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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