FDA Medical Device Recalls (openFDA)
Innovasis, Inc: Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag. Product Usage: 4.5mm x 14mm Anterior Cervical Plate System Variable Rescue Screw. The Opteryx Cervical Plate System is intended as a temporary fixation device used for correction and stabilization of the cervical spine. Variable angle screws are included to allow the physician greater flexibility when placing the plates and securing it to the vertebrae.
- Recall number
- Z-2153-2017
- Recalling firm
- Innovasis, Inc
- Product
- Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$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.
- Status
- Terminated
- Initiated
- 2017-05-05
- Posted
- 2017-05-23
- Terminated
- 2017-08-01
- Reason
- Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14).
- Root cause
- 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
- 21
- Distribution
- US Nationwide Distribution in the states of CA, UT, ID, TX, OH, and MN.
- Lot, serial or model codes
- Lot #1601
- 510(k) numbers
- ["K061147"]
- PMA numbers
- not on file
- Product code
- KWQ
- Firm FEI
- 3004719693
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28