FDA Medical Device Recalls (openFDA)
Biomet, Inc.: Comprehensive Shoulder Instruments Primary Shoulder Stem Inserter, REF 407398, Biomet Orthopedics Warsaw, IN, Instrument used to introduce the stem into the canal. The instrument is used to insert the shoulder implant into the shoulder.
- Recall number
- Z-2712-2011
- Recalling firm
- Biomet, Inc.
- Product
- Comprehensive Shoulder Instruments Primary Shoulder Stem Inserter, REF 407398, Biomet Orthopedics Warsaw, IN, Instrument used to introduce the stem into the canal. The instrument is used to insert the shoulder implant into the shoulder.
- Status
- Terminated
- Initiated
- 2011-04-07
- Posted
- 2011-06-30
- Terminated
- 2013-04-08
- Reason
- When the surgeon attempts to remove the inserter from the stem, the inserter may become stuck not allowing it to disengage from the stem. The stem may have to be removed from the patient in order to disengage the inserter from the stem. If the stem is removed from the patient, it could potentially cause a significant delay in the procedure or damage/fracture of the humerus which may require inter
- Root cause
- Nonconforming Material/Component
- Action
- The firm, Biomet Orthopedics, sent two "URGENT MEDICAL DEVICE RECALL NOTICE" letters one dated April 7, 2011 and the second letter dated April 12, 2011 which included an additional lot number, to its customers. The letters described the product, problem and actions to be taken. The customers were instructed to immediately locate and discontinue use of the noted product; carefully follow the instructions on the enclosed "FAX Back Response Form"; complete and return the Fax Response Form within three (3) business days via fax to 574-372-1683; use priority carrier for their shipment; If the product was further distributed, they MUST notify and give letter to Hospital personnel, and confirm receipt of this notice by calling, 800-348-9500, extension 3755 or 3756. Questions related to this notice should be directed to 574-371-3755 or 574-371-3756, Monday through Friday, 8AM to 5PM.
- Quantity
- 469 units both products
- Distribution
- Worldwide distribution: USA (nationwide) including Puerto Rico; and countries of: Australia, Canada, Chile, Columbia, Costa Rica, Italy, Japan, Korea, Netherlands, New Zealand, Spain and Sweden.
- Lot, serial or model codes
- 043190, 176120, 176130, 176140, 176150, 176870, 176900, 281960, 296760, 296770, 296780, 599260, 678800, 775960, 775980, 806060, 832070, 859290 and 884850.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- 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