Ref, S331140 Selex M2A Magnum Modular Head, 40 mm head diameter plus 3 mm neck,1 Taper, Sterile, Biomet Orthopedics, War

FDA device recall Z-1449-2012 · posted 2012-04-23 · Terminated

Recall details

Recalling firm

Biomet, Inc.

Reason for recall

Devices with a specification for a +6mm neck length were incorrectly labeled for a +3mm neck length specification.

Action taken

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

Status

Terminated

Product code

LZO

Quantity affected

5 devices

Distribution

USA Nationwide Distribution including the states of: MI, NC., OK and WI.

Date initiated

2011-09-13

Date posted

2012-04-23

Date terminated

2013-02-21

Location

Warsaw, IN

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