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.
FDA Recall Z-2153-2017 · Posted 2017-05-23
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Recalling FirmInnovasis, Inc
Recall StatusTerminated
Product CodeKWQ
Date Initiated2017-05-05
Date Terminated2017-08-01
Product Quantity21
Reason for Recall
Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14).
Firm Action
Distributors are being notified by e-mail, with attached copies of the written letter and forms to be printed, signed and returned to Innovasis on 5/5/17. Additional follow-up may be done via telephone and fax to return products.
Root Cause
Error in labeling
Distribution Pattern
US Nationwide Distribution in the states of CA, UT, ID, TX, OH, and MN.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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