Ref, S331140 Selex M2A Magnum Modular Head, 40 mm head… recallZ-1449-2012 · Biomet, Inc. · initiated Sep 13, 2011
Terminated All recalls posted in April 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Devices with a specification for a +6mm neck length were incorrectly labeled for a +3mm neck length specification.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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).
Recall details
- Recall number
- Z-1449-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 13, 2011
- Posted by the FDA
- Apr 23, 2012
- Recalling firm
- Biomet, Inc.
- Quantity
- 5 devices
- Product code
- LZO
- FDA submissions
- K062997
- Distribution
- USA Nationwide Distribution including the states of: MI, NC., OK and WI.
Product description
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
Code information (models, lots, serial numbers)
Part S331140, Lot 446970
Other devices under the same FDA submission
2 devices cleared under K062997 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- RingLoc® Hip System XL-108223Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 recall0 reports
- RingLoc® Hip System XL-108323Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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