FDA Medical Device Recalls (openFDA)
Biomet, Inc.: 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
- Recall number
- Z-1449-2012
- Recalling firm
- Biomet, Inc.
- 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
- Status
- Terminated
- Initiated
- 2011-09-13
- Posted
- 2012-04-23
- Terminated
- 2013-02-21
- Reason
- Devices with a specification for a +6mm neck length were incorrectly labeled for a +3mm neck length specification.
- 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
- 5 devices
- Distribution
- USA Nationwide Distribution including the states of: MI, NC., OK and WI.
- Lot, serial or model codes
- Part S331140, Lot 446970
- 510(k) numbers
- ["K062997"]
- PMA numbers
- not on file
- Product code
- LZO
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28