3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System Product Usage: is in
FDA device recall Z-0921-2013 · posted 2013-03-08 · Terminated
Recall details
- Recalling firm
- Genesys Orthopedic Systems, LLC
- 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.
- Action taken
- Genesys Orthopedic Systems, LLC sent a Recall Notification letter dated February 20, 2013 to all affected customers. The letter identified the affected product, problem and necessary actions to be taken. Customers were instructed to immediately return the affected product to the Genesys Spine office and complete and return the enclosed Response Form as soon as possible. For questions call 512-381-7070.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- KWQ
- Quantity affected
- 9 cervical screws
- Distribution
- USA Nationwide Distribution including the states of: CA and TX.
- Date initiated
- 2013-02-20
- Date posted
- 2013-03-08
- Date terminated
- 2013-09-09
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GENESYS SPINE ANTERIOR CERVICAL PLATE SYSTEM (K111132) | Genesys Spine | 2011-12-09 |