Z-2153-2017 Class II Terminated
FDA device recall Z-2153-2017 was initiated by Innovasis, Inc on May 5, 2017 and is designated Class II. Reason for recall: Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14). The recall status is terminated (terminated August 1, 2017). Affected quantity: 21.
Recall Details
- Product Type
- Devices
- Report Date
- May 31, 2017
- Initiation Date
- May 5, 2017
- Termination Date
- August 1, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21
Product Description
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).
Distribution Pattern
US Nationwide Distribution in the states of CA, UT, ID, TX, OH, and MN.
Code Information
Lot #1601