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 Recall Z-1071-2012 · Posted 2012-02-21
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Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeJDC
Date Initiated2011-12-14
Date Terminated2012-12-12
Product Quantity10 units
Reason for Recall
A Discovery Condyle Kit w/ Hexalobula was opened during an elbow joint replacement surgery, and was found to contain two male condyles.
Firm Action
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.
Root Cause
Process change control
Distribution Pattern
International Only Distribution -- Netherlands & UK.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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