Opteryx Variable Rescue Screw — Class II medical device recall Z-2153-2017
Terminated recall by Innovasis, Inc, reported 2017-05-31, distributed nationwide. Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14).
| Recall number | Z-2153-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Innovasis, Inc, Salt Lake City, UT, United States |
| Recall initiated | 2017-05-05 |
| Classified | 2017-05-23 |
| Reported by FDA | 2017-05-31 |
| Terminated | 2017-08-01 |
| Distributed | Nationwide (US) |
| Quantity | 21 |
| Lot numbers | 1601 |
| Model numbers | CP2214 |
Product
Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag. Product Usage: 4.5mm x 14mm Anterior Cervical Plate System Variable Rescue Screw. The Opteryx¿ Cervical Plate System is intended as a temporary fixation device used for correction and stabilization of the cervical spine. Variable angle screws are included to allow the physician greater flexibility when placing the plates and securing it to the vertebrae.
Reason for recall
Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14).
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-2153-2017. 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.