Z-1536-2011

Cylindrical Bullet Nose Reamer 12.5 mm x 250 mm, REF 475813, Biomet Orthopedics 66 East Bell Drive Warsaw IN...

Name: Z-1536-2011 Cylindrical Bullet Nose Reamer 12.5 mm x 250 mm, REF 475813, Biomet Orthopedics 66 East Bell Drive Warsaw IN...
Creator: Biomet, Inc.
Published: 2010-12-23
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2010-12-23 / Terminated / root cause: supplier

FDA source

Biomet, Inc. began a recall of Cylindrical Bullet Nose Reamer 12.5 mm x 250 mm, REF 475813, Biomet Orthopedics 66 East Bell Drive Warsaw IN. The product is used to prepare the femoral canal... on 2010-12-23. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1536-2011
Status: Terminated
Initiated: 2010-12-23
Posted: 2011-03-04
Terminated: 2012-10-01
Recalling firm: Zimmer GmbH
Product: Cylindrical Bullet Nose Reamer 12.5 mm x 250 mm, REF 475813, Biomet Orthopedics 66 East Bell Drive Warsaw IN. The product is used to prepare the femoral canal for stem implantation.
Product code: HTO Reamer
Reason for recall: 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 tag: supplier
FDA 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 in commerce: 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.
Product codes and lots: 060890, 077020 and 605240.

Product code HTO

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)