Z-1449-2012

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

Name: Z-1449-2012 Ref, S331140 Selex M2A Magnum Modular Head, 40 mm head diameter plus 3 mm neck,1 Taper, Sterile, Biomet...
Creator: Biomet, Inc.
Published: 2011-09-13
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2011-09-13 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of 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... on 2011-09-13. The reason FDA records is "Devices with a specification for a +6mm neck length were incorrectly labeled for a +3mm neck length specification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1449-2012
Status: Terminated
Initiated: 2011-09-13
Posted: 2012-04-23
Terminated: 2013-02-21
Recalling firm: Zimmer GmbH
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
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: Devices with a specification for a +6mm neck length were incorrectly labeled for a +3mm neck length specification.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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).
Quantity in commerce: 5 devices
Distribution: USA Nationwide Distribution including the states of: MI, NC., OK and WI.
Product codes and lots: Part S331140, Lot 446970

Product code LZO

K062997Class IIArcomxl Polyethylene Liners and 38/40Mm Femoral HeadsBiomet Manufacturing Corp / cleared 2006-12-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)