Z-0474-2013Class II

Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant)

Name: Z-0474-2013 Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant)
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 Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product Usage: The OSS Knee Reamer Sleeves are primarily used to guide the... on 2012-11-01. FDA classified it as Class II and gives the reason as "The items in this lot are missing the ion implantation feature. The surface of the head may be softer and more prone to scratching, which in tum could potentially cause higher wear of the poly bearing. Increased wear...". 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-0474-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-01
Posted: 2012-12-05
Terminated: 2013-08-29
Recalling firm: Zimmer GmbH
Product: Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product Usage: 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: KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Reason for recall: The items in this lot are missing the ion implantation feature. The surface of the head may be softer and more prone to scratching, which in tum could potentially cause higher wear of the poly bearing. Increased wear could potentially lead to a shorter implant life.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Biomet, Inc. sent an URGENT MEDICAL DEVICE RECALL NOTICE dated November 1, 2012 to all affected consignees. The letter identified the affected product, problem and actions to be taken. The notification letter instructed the surgeon to montior the patient as their is a potential for increased wear which have an unknown effect on implant life. For questions call 574-372-1570.
Quantity in commerce: 4
Distribution: USA Nationwide Distribution in the state of WI.
Product codes and lots: Catalog Number: 113740 and Lot Number Identification: 779270

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0474-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0474-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-12	2012-12-04

Product code KWT

K030710Class IIBio-Modular Shoulder SystemBiomet, Inc. / cleared 2003-06-04

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)