Reported Mar 20, 2013 · Terminated
3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System Product Usage: is…
Genesys Orthopedic Systems, LLC
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: Genesys Orthopedic Systems, LLC · 1250 S Capital Of Texas Hwy · Austin, TX · 78746-6446
Is this the product you have?
- 3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior
- Cervical Plate System Product Usageis intended for anterior screw fixation to the cervical spine
- Lot codes and dates
- Part NumberGCSF37512
- and Lot Number0243
- Amount recalled
- 9 cervical screws
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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