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U.S. Department of Health and Human Services

Class 2 Device Recall Opteryx Variable Rescue Screw

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  Class 2 Device Recall Opteryx Variable Rescue Screw see related information
Date Initiated by Firm May 05, 2017
Date Posted May 23, 2017
Recall Status1 Terminated 3 on August 01, 2017
Recall Number Z-2153-2017
Recall Event ID 77206
510(K)Number K061147  
Product Classification Appliance, fixation, spinal intervertebral body - Product Code KWQ
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.
Code Information Lot #1601
Recalling Firm/
Innovasis, Inc
614 E 3900 S
Salt Lake City UT 84107-1902
Manufacturer Reason
for Recall
Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14).
FDA Determined
Cause 2
Error in labeling
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.
Quantity in Commerce 21
Distribution US Nationwide Distribution in the states of  CA, UT, ID, TX, OH, and MN.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KWQ and Original Applicant = INNOVASIS, INC.