FDAFDA · Food and drugs·Recall number Z-2153-2017
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.
Published May 31, 2017 · Recall initiated: May 5, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14).
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Innovasis, Inc
- Distributor
- US Nationwide Distribution in the states of CA, UT, ID, TX, OH, and MN.
- Lot
- Lot #1601
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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