—#105901

Product

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 product code: LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K062997
Affected lot / code info: Part S331140, Lot 446970

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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).

Recalling firm

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

Distribution

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

Timeline

Recall initiated: 2011-09-13
Posted by FDA: 2012-04-23
Terminated: 2013-02-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #105901. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.