FDAFDA · Food and drugs·Recall number Z-0921-2013
3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System Product Usage: is intended for anterior screw fixation to the cervical spine.
Published March 20, 2013 · Recall initiated: February 20, 2013
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
Manufacturing residue may be present on the cervical screws. Use of this product may result in patient infection, delayed fusion or non-fusion (pseudarthrosis), inflammatory response, or revision surgery.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Genesys Orthopedic Systems, LLC
- Distributor
- USA Nationwide Distribution including the states of: CA and TX.
- Lot
- Part Number: GCSF37512 and Lot Number: 0243
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.