Reported May 31, 2017 · Terminated
Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag.…
Innovasis, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Innovasis, Inc · 614 E 3900 S · Salt Lake City, UT · 84107-1902
Is this the product you have?
- Opteryx Variable Rescue Screw, Part #CP2214
- UDI*+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag
- Product Usage4.5mm 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
- Lot codes and dates
- Lot #1601
- Amount recalled
- 21
Where it was sold
Why it was recalled
Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14).
This product could cause temporary or reversible health problems — stop using it.
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