FDA Medical Device Recalls (openFDA)
Biomet, Inc.: Cylindrical Bullet Nose Reamer 11.5 mm x 250 mm, REF 475811, Biomet Orthopedics 66 East Bell Drive Warsaw IN. The product is used to prepare the femoral canal for stem implantation.
- Recall number
- Z-1534-2011
- Recalling firm
- Biomet, Inc.
- Product
- Cylindrical Bullet Nose Reamer 11.5 mm x 250 mm, REF 475811, Biomet Orthopedics 66 East Bell Drive Warsaw IN. The product is used to prepare the femoral canal for stem implantation.
- Status
- Terminated
- Initiated
- 2010-12-23
- Posted
- 2011-03-04
- Terminated
- 2012-10-01
- Reason
- The firm was notified by their supplier that during manufacture of this instrument, the 12 degree cutting edge was not created. Testing found that if the cutting edge is missing, the reamer will not perform as intended.
- Root cause
- Other
- Action
- The firm, BIOMET, sent an" URGENT MEDICAL DEVICE RECALL NOTICE" dated December 23, 2010 to its customers. The notice described the product, problem and actions to be taken by the customer. The customers were instructed to immediately locate, discontinue use of product and return the product to Biomet. Biomet distributors were told to notify hospital personnel of the recall if they had distributed the product to hospital customers. The Customers/Distributors were instructed to confirm receipt of the notice by calling 800-348-9500 extension 3755 and 3983 and to complete and return the Response Form included with the recall notice via fax to 574-372-1683. Questions related to this notice should be directed to 574-371-3755 or 574-372-3983, Monday through Friday, 8am to 5pm.
- Quantity
- 51 all products
- Distribution
- Worldwide distribution: USA including states of: FL, OH, PA, IN, CA, and NJ; and countries of Argentina, Canada, Mexico, Netherlands and Spain.
- Lot, serial or model codes
- 833220
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HTO
- 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