Device 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.
Z-2153-2017
Product summary
- Firm
- Innovasis, Inc
- Event
- Event 77206
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21
- Official record key
device-enforcement:Z-2153-2017
Official wording
Reason: Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14).
Code information: Lot #1601
Distribution pattern: US Nationwide Distribution in the states of CA, UT, ID, TX, OH, and MN.
Derived failure modes
-
Unknown
Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14).