FDA Device recall Z-0921-2013
3.75mm x 12mm Fixed Cervical Screws
- FDA Device
- Class II
- terminated
- Published 2013-03-20
On 2013-03-20 the FDA classified a Class II recall of 3.75mm x 12mm Fixed Cervical Screws by Genesys Orthopedic Systems, citing 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 respo….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0921-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-20 |
| Published | 2013-03-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Genesys Orthopedic Systems |
| Distribution | US |
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.
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.
Identifiers
| code_info | Part Number: GCSF37512 and Lot Number: 0243 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0921-2013%22
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