Z-0471-2013Class II

OSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8.0 THRU 12.5 STAINLESS STEEL The OSS Knee Reamer Sleeves...

Name: Z-0471-2013 OSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8.0 THRU 12.5 STAINLESS STEEL The OSS Knee Reamer Sleeves...
Creator: Biomet, Inc.
Published: 2012-11-01
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2012-11-01 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of OSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8.0 THRU 12.5 STAINLESS STEEL The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of... on 2012-11-01. FDA classified it as Class II and gives the reason as "Biomet has initiated this action following an investigation which identified that the thin shaft reamer may get stuck and not slide into the sleeve". 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-0471-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-01
Posted: 2012-12-04
Terminated: 2013-04-29
Recalling firm: Zimmer GmbH
Product: OSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8.0 THRU 12.5 STAINLESS STEEL The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.
Product code: HTO Reamer
Reason for recall: Biomet has initiated this action following an investigation which identified that the thin shaft reamer may get stuck and not slide into the sleeve.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Biomet, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter dated November 1, 2012 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately locate, discontinue use of and remove the product from circulation; and return recalled devices with directions to distribute notices, if product was further distributed; and to complete and return the enclosed FAX Back Response Form within three (3) business days to FAX # 574-372-1683. Distributors were charged with locating and returning products to Biomet ATTN: Return Goods-Building B RECALLS RGA#: _, Biomet, Inc., 56 East Bell Drive, Warsaw, IN 46580. Questions should be directed to the Field Action Coordinator at (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m
Quantity in commerce: 46
Distribution: Worldwide distribution: USA (nationwide) and countries of: Japan and Netherlands.
Product codes and lots: Part Numbers 32-472661 , 8.0 thru 12.5 Lot 013020, 050310, 056280, 154670, 418380, 691220, 755510, 860171, 866460

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0471-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0471-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-12	2012-12-04
Z-0472-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-12	2012-12-04

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)