—#106933

Product

Discovery Elbow System Humeral Condyle Set- Hexalobular, REF 114700, Lot 797550 Alloy, Sterile, Biomet Orthopedics Warsaw IN 46581. 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: REF 114700, Lot 797550

Why it was recalled

A Discovery Condyle Kit w/ Hexalobula was opened during an elbow joint replacement surgery, and was found to contain two male condyles.

Root cause (FDA determination)

Process change control

Action the firm took

December 14, 2011 Urgent Medical Device Recall Notices were sent to Distributors and hospital OR managers describing the product, problem, risks associated with the recall, and actions to be taken. The notice included Instructions to locate and remove the product. Customers were asked to complete a response form and fax to 574-372-1683, prior to returning product by priority mail to the attention of Angi Dickson, Biomet , 56 East Bell Drive Warsaw, IN, USA 46580 with a copy of the response form. Receipt of the notice should also be confirmed by calling 800-348-9500, extension 3983 or 3009. Questions related to this notice should be directed to 574-371-3983 or 574-371-3009 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: International Only Distribution -- Netherlands & UK.

Timeline

Recall initiated: 2011-12-14
Posted by FDA: 2012-02-21
Terminated: 2012-12-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #106933. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.