Biomet, Inc.: Medical Device Recall in 2012 - (Recall #: Z-0474-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: November 1, 2012

Date Posted: December 12, 2012

Recall Number: Z-0474-2013

Event ID: 63708

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.

Status: Terminated

Product Quantity: 4

Code Information:

Catalog Number: 113740 and Lot Number Identification: 779270

Distribution Pattern:

USA Nationwide Distribution in the state of WI.

Voluntary or Mandated:

Voluntary: Firm initiated