Z-2372-2008

Exact Calcar Planer Rasp Style Blade, 46mm, Biomet Orthopedics, Inc, Warsaw, IN; REF 31-473797. Surgical...

Name: Z-2372-2008 Exact Calcar Planer Rasp Style Blade, 46mm, Biomet Orthopedics, Inc, Warsaw, IN; REF 31-473797. Surgical...
Creator: Biomet, Inc.
Published: 2008-07-18
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2008-07-18 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of Exact Calcar Planer Rasp Style Blade, 46mm, Biomet Orthopedics, Inc, Warsaw, IN; REF 31-473797. Surgical blades used to remove excess bone proximal to the... on 2008-07-18. The reason FDA records is "The blades will oxidize after the first cleaning". 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-2372-2008
Status: Terminated
Initiated: 2008-07-18
Posted: 2008-09-29
Terminated: 2009-06-26
Recalling firm: Zimmer GmbH
Product: Exact Calcar Planer Rasp Style Blade, 46mm, Biomet Orthopedics, Inc, Warsaw, IN; REF 31-473797. Surgical blades used to remove excess bone proximal to the broach face to all instrument trial to seat properly.
Product code: GFA Blade, Saw, General & Plastic Surgery, Surgical
Reason for recall: The blades will oxidize after the first cleaning.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Distributors were notified via letter dated 7/18/08 to locate and remove the products and to return them. Distributors were instructed to conduct the recall to the hospital level and to notify the hospitals of the recall by copy of an undated recall letter. Contact Biomet, Inc. at 1-800-348-9500, ext. 3983 for assistance.
Quantity in commerce: 141 of all products
Distribution: Nationwide and China.
Product codes and lots: Lots 850560, 439390, 848560 and 918030.

Product code GFA

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