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Innovasis, Inc recalls Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag. P
Recalled May 31, 2017 · FDA recall Z-2153-2017 · Innovasis
Hazard
Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14). · FDA Class II
Units
21
Sold at
US Nationwide Distribution in the states of CA, UT, ID, TX, OH, and MN.
Description
Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14).
Product
Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$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.
Manufacturer(s)
Innovasis, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →