Recall Z-0921-2013— Genesys Orthopedic Systems, LLC
Class II · Terminated
Class II FDA medical device recall by Genesys Orthopedic Systems, LLC, initiated 2013-02-20, terminated 2013-09-09. It names one FDA 510(k) clearance: K111132. Product: 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: 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..
- Recalling firm
- Genesys Orthopedic Systems, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-02-20
- Terminated
- 2013-09-09
- Firm location
- Austin, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.