3.75mm x 12mm Fixed Cervical Screws. Components of the recall
3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System Product Usage: is intended for anterior screw…
Why was 3.75mm x 12mm Fixed Cervical Screws. Components of the 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Number: GCSF37512 and Lot Number: 0243
- Product
- 3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System Product Usage: is intended for anterior screw…
- Recalling firm
- Genesys Orthopedic Systems, LLC
- Quantity
- 9 cervical screws
- Distribution
- USA Nationwide Distribution including the states of: CA and TX.
- Recall date
- March 20, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)