Z-0288-2009

Biomet 2.0 MM Stainless Steel (SS) Crimp Sleeve, sterile, use w/2.0 MM S.S. cable # 350800, Biomet...

Name: Z-0288-2009 Biomet 2.0 MM Stainless Steel (SS) Crimp Sleeve, sterile, use w/2.0 MM S.S. cable # 350800, Biomet...
Creator: Biomet, Inc.
Published: 2008-09-24
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2008-09-24 / Terminated / root cause: labeling and UDI

FDA source

Biomet, Inc. began a recall of Biomet 2.0 MM Stainless Steel (SS) Crimp Sleeve, sterile, use w/2.0 MM S.S. cable # 350800, Biomet Orthopedics, Inc., Warsaw, IN; REF. 350805. Intended for... on 2008-09-24. The reason FDA records is "The outer package is properly labeled, but the inner package may be labeled as a femoral component". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0288-2009
Status: Terminated
Initiated: 2008-09-24
Posted: 2008-11-09
Terminated: 2009-06-29
Recalling firm: Zimmer GmbH
Product: Biomet 2.0 MM Stainless Steel (SS) Crimp Sleeve, sterile, use w/2.0 MM S.S. cable # 350800, Biomet Orthopedics, Inc., Warsaw, IN; REF. 350805. Intended for general orthopedic repairs including long bone fractures, bone grafting, reinforcement of bone and reattachment of the greater trochanter.
Product code: JDQ Cerclage, Fixation
Reason for recall: The outer package is properly labeled, but the inner package may be labeled as a femoral component.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: The firm's sales force was notified of the problem via an Urgent Medical Device Removal Notice letter dated 9/24/08, and provided instructions to retrieve the product from customer accounts and to provide them with a copy of the removal letter. Distributors were to immediately locate and remove the identified implants from circulation, carefully follow the instructions, and fax a copy of the Response Form prior to the return of the product. If the product was further distributed, hospital personnel MUST be notified via the enclosed "Dear Biomet Customer" notice. The letter MUST be given to hospital personnel responsible for receiving recall notices but distributors are charged with the location and return of those products.
Quantity in commerce: 48
Distribution: Worldwide Distribution --- USA including states of Arkansas, Florida, Kansas, New Jersey, and Ohio, and countries of Argentina, Canada, Chile Italy, Mexico and United Kingdom.
Product codes and lots: Lot 568400.

Product code JDQ

K982545Class IIBmp Cable SystemBiomet, Inc. / cleared 1998-10-19

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)