3 — Class II medical device recall Z-0921-2013
Terminated recall by Genesys Orthopedic Systems, LLC, reported 2013-03-20, distributed nationwide. Manufacturing residue may be present on the cervical screws. Use of this product may result in patient infecti
| Recall number | Z-0921-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Genesys Orthopedic Systems, LLC, Austin, TX, United States |
| Recall initiated | 2013-02-20 |
| Classified | 2013-03-08 |
| Reported by FDA | 2013-03-20 |
| Terminated | 2013-09-09 |
| Distributed | Nationwide (US) |
| Quantity | 9 cervical |
| Lot numbers | 0243 |
| Model numbers | GCSF37512 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0921-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.