Z-0921-2013 Class II Terminated
FDA device recall Z-0921-2013 was initiated by Genesys Orthopedic Systems, LLC on February 20, 2013 and is designated Class II. Reason for recall: 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 sur… The recall status is terminated (terminated September 9, 2013). Affected quantity: 9 cervical screws.
Recall Details
- Product Type
- Devices
- Report Date
- March 20, 2013
- Initiation Date
- February 20, 2013
- Termination Date
- September 9, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 cervical screws
Product Description
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.
Reason for Recall
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.
Distribution Pattern
USA Nationwide Distribution including the states of: CA and TX.
Code Information
Part Number: GCSF37512 and Lot Number: 0243