FDA Medical Device Recalls (openFDA)
Biomet, Inc.: A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw
- Recall number
- Z-2058-2015
- Recalling firm
- Biomet, Inc.
- Product
- A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw
- Status
- Terminated
- Initiated
- 2015-06-04
- Posted
- 2015-07-10
- Terminated
- 2016-03-22
- Reason
- Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection.
- Root cause
- Packaging
- Action
- On 6/4/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors with instructions for removing the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday 8 a.m.to 5 p.m.
- Quantity
- 50 units
- Distribution
- Domestic: None. International: Netherlands and Japan
- Lot, serial or model codes
- Part number:856135060 Lot: 061300
- 510(k) numbers
- ["K111663"]
- PMA numbers
- not on file
- Product code
- HRS
- 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