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.
This recall has been terminated (originally issued May 23, 2017).
- Company
- Innovasis, Inc
- Recall Initiated
- May 5, 2017
- Posted
- May 23, 2017
- Terminated
- August 1, 2017
- Recall Number
- Z-2153-2017
- Quantity
- 21
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14).
Distribution
US Nationwide Distribution in the states of CA, UT, ID, TX, OH, and MN.
Lot / Code Info
Lot #1601
Root Cause
Error in labeling
Action Taken
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.
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