FDA Device recall Z-2153-2017
Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag
- FDA Device
- Class II
- terminated
- Published 2017-05-31
On 2017-05-31 the FDA classified a Class II recall of Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag by Innovasis, citing opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2153-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-05 |
| Published | 2017-05-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Innovasis |
| Distribution | US |
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
Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14).
Identifiers
| code_info | Lot #1601 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2153-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.