—#100452

Product

Condyle Kit with Hexalobular, REF 114700 DISCOVERY ELBOW SYSTEM, HUMERAL CONDYLE SET - HEXALOBULAR, CO-CR-MO / YI-GAL-4V ALLOY, IF USED FOR REVISION SURGERY, INSTRUMENTS 414926 & 414923 MAY BE REQUIRED LOT 183300, 1 SET, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE, P.O. BOX 587 WARSAW, IN 46581 USA EXPIRY DATE: 2021-03 Elbow joint replacement prosthesis intended for primary and revision joint arthroplasty for use in cemented applications.

FDA product code: JDC — Prosthesis, Elbow, Constrained, Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K051975
Affected lot / code info: LOT 183300

Why it was recalled

The firm initiated this recall after becoming aware that a Discovery Condyle Kit with Hexalobula contained two male condyles instead of a male and female condyle.

Root cause (FDA determination)

Packaging process control

Action the firm took

Biomet sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated May 25, 2011 to all affected customers. The notice describes the product, problem, and actions to be taken by the customers. The notice instructed customers to locate and remove the product. Customers were asked to complete a response form and fax to 574-372-1683, within 3 business days. Additionally, customers were instructed to ship the package priority mail with a copy of the response form. Questions related to this notice should be directed to 574-371-3755 or 574-371-3756, Monday through Friday 8 AM to 5 PM.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution--USA (nationwide) including the states of AR and SD and the country of Japan.

Timeline

Recall initiated: 2011-04-29
Posted by FDA: 2011-06-24
Terminated: 2011-08-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #100452. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.