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Biomet Offset Tibial Tray Adaptor, 5.0 MM, sterile, Biomet… recallZ-1061-2009 · Biomet, Inc. · initiated Feb 13, 2009

Terminated All recalls posted in April 2009

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Packaging process control

What the company is doing

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.

Recall details

Recall number
Z-1061-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Feb 13, 2009
Posted by the FDA
Apr 7, 2009
Recalling firm
Biomet, Inc.
Quantity
17
Product code
JDW
FDA submissions
K010212
Distribution
Worldwide Distribution including Germany, Italy, Netherlands, Spain and the United Kingdom.

Product description

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.

Code information (models, lots, serial numbers)

Lot 644290.

Other devices under the same FDA submission

19 devices cleared under K010212 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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