Ref, S331140 Selex M2A Magnum Modular Head, 40 mm head diameter plus 3 mm neck,1 Taper, Sterile, Biomet Orthopedics, Warsaw, IN Product Usage: Intended for use in non-cemented primary and revision hip joint replacement
FDA Recall Z-1449-2012 · Posted 2012-04-23
Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeLZO
Date Initiated2011-09-13
Date Terminated2013-02-21
Product Quantity5 devices
Reason for Recall
Devices with a specification for a +6mm neck length were incorrectly labeled for a +3mm neck length specification.
Firm Action
Biomet contacted consignees with device inventory by telephone on September 13, 2011 requesting all associated product be quarantined immediately. An Urgent Medical Device Recall Notice was sent via U.S. mail March 23, 2012 to consignees with directions to immediately locate, discontinue use of the affected product and return to Biomet. The letter instructed consignees to carefully follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product. The notification letter to consignees contained directions to confirm receipt of notice by calling 800-348-9500, extension 3983 or 3009. Questions concerning recall are directed to 574-372-3983 or 574371-3009 M-F 8 A.M. to 5 P.M. (ET).
Root Cause
Nonconforming Material/Component
Distribution Pattern
USA Nationwide Distribution including the states of: MI, NC., OK and WI.
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.