Z-0091-06

Zimmer brand Sirus Intramedullary femur nail system step reamer 0 mm, 6.5/4.5 mm cannulated, for cervical...

Name: Z-0091-06 Zimmer brand Sirus Intramedullary femur nail system step reamer 0 mm, 6.5/4.5 mm cannulated, for cervical...
Creator: Zimmer Inc.
Published: 2005-09-30
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2005-09-30 / Terminated / root cause: manufacturing process

FDA source

Zimmer Inc. began a recall of Zimmer brand Sirus Intramedullary femur nail system step reamer 0 mm, 6.5/4.5 mm cannulated, for cervical screws, item number 02.00020.039 on 2005-09-30. The reason FDA records is "The calibrations on the reamers may lead to inaccurate reaming depth when used in accordance with the published surgical technique". 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-0091-06
Status: Terminated
Initiated: 2005-09-30
Posted: 2005-10-28
Terminated: 2005-12-28
Recalling firm: Zimmer GmbH
Product: Zimmer brand Sirus Intramedullary femur nail system step reamer 0 mm, 6.5/4.5 mm cannulated, for cervical screws, item number 02.00020.039.
Product code: GFG Bit, Surgical
Reason for recall: The calibrations on the reamers may lead to inaccurate reaming depth when used in accordance with the published surgical technique.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Consignees were notified via recall letter dated 9/30/05.
Quantity in commerce: 27
Distribution: Arizona, California, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Minnesota, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah and Virginia.
Product codes and lots: Lots 480103, 480104 and 487665.

Product code GFG

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)