Z-1061-2009

Biomet Offset Tibial Tray Adaptor, 5.0 MM, sterile, Biomet Orthopedics, Inc., Warsaw, IN, REF 141491. The...

Name: Z-1061-2009 Biomet Offset Tibial Tray Adaptor, 5.0 MM, sterile, Biomet Orthopedics, Inc., Warsaw, IN, REF 141491. The...
Creator: Biomet, Inc.
Published: 2009-02-13
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2009-02-13 / Terminated / root cause: packaging

FDA source

Biomet, Inc. began a recall of 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... on 2009-02-13. The reason FDA records is "A 2.5mm locking insert was packaged with the 5.0mm Offset Tibial Tray Adaptor instead of the 5.0mm locking insert". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1061-2009
Status: Terminated
Initiated: 2009-02-13
Posted: 2009-04-07
Terminated: 2009-08-11
Recalling firm: Zimmer GmbH
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.
Product code: JDW Pin, Fixation, Threaded
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.
Root cause tag: packaging
FDA root cause: Packaging process control
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.
Quantity in commerce: 17
Distribution: Worldwide Distribution including Germany, Italy, Netherlands, Spain and the United Kingdom.
Product codes and lots: Lot 644290.

Product code JDW

K010212Class IIOffset Tibial TrayBiomet, Inc. / cleared 2001-02-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)