FDA Medical Device Recalls (openFDA)
Biomet, Inc.: Exact Calcar Planer Rasp Style Blade, 38mm, Biomet Orthopedics, Inc, Warsaw, IN; REF 31-473795. Surgical blades used to remove excess bone proximal to the broach face to all instrument trial to seat properly.
- Recall number
- Z-2370-2008
- Recalling firm
- Biomet, Inc.
- Product
- Exact Calcar Planer Rasp Style Blade, 38mm, Biomet Orthopedics, Inc, Warsaw, IN; REF 31-473795. Surgical blades used to remove excess bone proximal to the broach face to all instrument trial to seat properly.
- Status
- Terminated
- Initiated
- 2008-07-18
- Posted
- 2008-09-29
- Terminated
- 2009-06-26
- Reason
- The blades will oxidize after the first cleaning.
- 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
- 141 of all products
- Distribution
- Nationwide and China.
- Lot, serial or model codes
- Lots 739370, 442250, 848550 and 904090.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GFA
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28