—#114592

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.

FDA product code: KWT — Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K030710
Affected lot / code info: Catalog Number: 113740 and Lot Number Identification: 779270

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: USA Nationwide Distribution in the state of WI.

Timeline

Recall initiated: 2012-11-01
Posted by FDA: 2012-12-05
Terminated: 2013-08-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #114592. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.