FDA Medical Device Recalls (openFDA)
Zimmer Biomet, Inc.: Biomet DVR Crosslock Screws- 2.7mm x18mm, Sterile ITEM 131827118 Product Usage: Usage: The system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions (osteotomies) of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, particularly in osteopenic bone
- Recall number
- Z-0709-2019
- Recalling firm
- Zimmer Biomet, Inc.
- Product
- Biomet DVR Crosslock Screws- 2.7mm x18mm, Sterile ITEM 131827118 Product Usage: Usage: The system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions (osteotomies) of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, particularly in osteopenic bone
- Status
- Terminated
- Initiated
- 2018-11-20
- Posted
- not on file
- Terminated
- 2020-04-14
- Reason
- One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking screws and one lot of product labeled 2.7mm x 20mm Lock Screw Square Drive (Lot 029980) contains 18mm locking screws
- Root cause
- Packaging process control
- Action
- Zimmer Biomet issued Urgent Medical Device Recall letter on 11/20/18 advising of the problem, heath risk and action to be taken- Quarantine and return product. Complete Attachment 1 Certificate of Acknowledgement. Contact customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday.
- Quantity
- 50 pieces
- Distribution
- Country of Japan
- Lot, serial or model codes
- LOT 029970 UDI (01)00880304535572(17)280501(10)029970
- 510(k) numbers
- ["K112345"]
- PMA numbers
- not on file
- Product code
- LXT
- 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