Z-1529-2009

Biomet OSS Letson Proximal Femoral Trial 7 cm resection/left, stainless steel, Biomet Orthopedics, Inc...

Name: Z-1529-2009 Biomet OSS Letson Proximal Femoral Trial 7 cm resection/left, stainless steel, Biomet Orthopedics, Inc...
Creator: Biomet, Inc.
Published: 2009-05-19
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2009-05-19 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of Biomet OSS Letson Proximal Femoral Trial 7 cm resection/left, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472089. A non-powered, orthopedic... on 2009-05-19. The reason FDA records is "The retaining ring may fall out of the instrument during surgery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1529-2009
Status: Terminated
Initiated: 2009-05-19
Posted: 2009-06-29
Terminated: 2010-10-08
Recalling firm: Zimmer GmbH
Product: Biomet OSS Letson Proximal Femoral Trial 7 cm resection/left, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472089. A non-powered, orthopedic manual surgical instrument for use with other devices in orthopedic surgery.
Product code: KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Reason for recall: The retaining ring may fall out of the instrument during surgery.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Distributors and consignees were notified by an Urgent Medical Device Recall Notice dated 5/19/09. Distributors and consignees were instructed to locate and remove the devices from circulation, carefully follow the instructions on the "FAX Back Response Form," and fax a copy of the Response Form to 574-372-1683 prior to return of the product. If the product has been further distributed, consignees must notify hospital personnel responsible for receiving recall notices of the action, via the enclosed "Dear Biomet Customer" notice. Consignees are responsible for the location and return of products to the firm. The letter stated that the instruments would be reworked and returned.
Quantity in commerce: 387 of all products
Distribution: Worldwide Distribution -- USA, Australia, Belgium, Canada, Costa Rica, Finland, France, Germany, Mexico, New Zealand, Poland, South Wales, and Spain.
Product codes and lots: All lots. Lots 063960, 115390, 115460, 197210, 206280, 238310, 252780, 397280, 405110, 444100, 444110, 488440, 506470, 536100, 632470, 635860, 641450, 721420, 775240, 793530, 797790, 839640, 849140, 892440, 894240 and 895840.

Product code KRO

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)