Z-1455-05

Biomet Maxim SI knee instruments sliding femoral 4-in-1 block, 60 mm, stainless steel; Ref. RD140530

Name: Z-1455-05 Biomet Maxim SI knee instruments sliding femoral 4-in-1 block, 60 mm, stainless steel; Ref. RD140530
Creator: Biomet, Inc.
Published: 2005-05-16
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2005-05-16 / Terminated

FDA source

Biomet, Inc. began a recall of Biomet Maxim SI knee instruments sliding femoral 4-in-1 block, 60 mm, stainless steel; Ref. RD140530 on 2005-05-16. The reason FDA records is "The instrument may have been assembled improperly, which may result in reversed resection cuts on the femur and affect implant performance, resulting in the need for revision surgery". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1455-05
Status: Terminated
Initiated: 2005-05-16
Posted: 2005-08-31
Terminated: 2005-09-08
Recalling firm: Zimmer GmbH
Product: Biomet Maxim SI knee instruments sliding femoral 4-in-1 block, 60 mm, stainless steel; Ref. RD140530.
Product code: HTZ Instrument, Cutting, Orthopedic
Reason for recall: The instrument may have been assembled improperly, which may result in reversed resection cuts on the femur and affect implant performance, resulting in the need for revision surgery.
FDA root cause: Other
Action: Biomet distributors were issued a letter dated 5/16/05 instructing them to locate the instruments and conduct a field inspection of the instruments to verify the pin location offset and ensure the correct orientation of the anterior marking on the slide component.
Quantity in commerce: 262
Distribution: Nationwide, Australia, Austria, Belgium, Canada, Costa Rica, Denmark, Finland, Greece, Israel, Japan, Mexico, Netherlands, New Zealand, South Korea, Spain, and the United Kingdom.
Product codes and lots: Lots 692030, 847270, 893240, 991260, 103470, 103440, 136560, 271330, 170710, 356500, 399630, 399640, 564090, 712190, 744790, 757850, 770410, 994540 and 863650.

Product code HTZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)