—#138113

Product

Oxford Femoral Drill Guide Lateral IM Adapter Product Usage: Drill guide. The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. Partial replacement of the articulating surfaces of the knee when only one side of the knee joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous partial arthroplasty in the affected compartment. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

FDA product code: HWT — Template
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Part Number: 32-423400 Lot Numbers: 238220, 664720,489620, 490930,021410, 507150

Why it was recalled

Oxford Femoral Drill Guide Lateral IM Adapter may have an undersized diameter that can cause an interference with PN: 32-422822, Oxford Microplasty IM Link.

Root cause (FDA determination)

Component design/selection

Action the firm took

On 6/3/2015 an "URGENT MEDICAL DEVICE RECALL NOTICE" letter was sent to the affected distributors with instructions for locating and returning the affected product. The recall letter included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide in the states of NC, IN, PA, OH and the country of the Netherlands.

Timeline

Recall initiated: 2015-06-03
Posted by FDA: 2015-07-14
Terminated: 2016-03-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #138113. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.