FDA Medical Device Recalls (openFDA)
Genesys Orthopedic Systems, LLC: 3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System Product Usage: is intended for anterior screw fixation to the cervical spine.
- Recall number
- Z-0921-2013
- Recalling firm
- Genesys Orthopedic Systems, LLC
- Product
- 3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System Product Usage: is intended for anterior screw fixation to the cervical spine.
- Status
- Terminated
- Initiated
- 2013-02-20
- Posted
- 2013-03-08
- Terminated
- 2013-09-09
- Reason
- Manufacturing residue may be present on the cervical screws. Use of this product may result in patient infection, delayed fusion or non-fusion (pseudarthrosis), inflammatory response, or revision surgery.
- Root cause
- Employee error
- Action
- Genesys Orthopedic Systems, LLC sent a Recall Notification letter dated February 20, 2013 to all affected customers. The letter identified the affected product, problem and necessary actions to be taken. Customers were instructed to immediately return the affected product to the Genesys Spine office and complete and return the enclosed Response Form as soon as possible. For questions call 512-381-7070.
- Quantity
- 9 cervical screws
- Distribution
- USA Nationwide Distribution including the states of: CA and TX.
- Lot, serial or model codes
- Part Number: GCSF37512 and Lot Number: 0243
- 510(k) numbers
- ["K111132"]
- PMA numbers
- not on file
- Product code
- KWQ
- Firm FEI
- 3008455034
- Firm city
- Austin
- Firm state
- TX
- 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