Device product
Calix P PEEK Lumbar System, PLIF Rasp
Z-0124-2017
Product summary
- Event
- Event 74397
- Status
- Terminated
- Classification
- Class II
- Quantity
- 182 units
- Official record key
device-enforcement:Z-0124-2017
Official wording
Reason: The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in the intervertebral space.
Code information: Size, 22mm x 10mm x 6mm, Part #:, X034-0990, Lot #:, 015641-2-1, 015641-2-1R, 015857-24-1, 020316, 020329, 020746, 19894, UP1009, UPI002, UPI005, UPI008 & Size, 22mm x 10mm x 10mm, Part #:, X034-0994, Lot #:, 015641-3-1, 015641-3-1R,015857-25-1, 020317, 020330, 020747, UPI001, UPI004, UPI007.
Distribution pattern: Product was shipped to the following states: AZ, CA, CO, FL, GA, ID, IN, KY, LA, MD, MI, MO, NC, NV, NY, PA, PR, TX & WV. Product was also shipped to the following countries: Australia, England, Germany, Italy, Mexico, Portugal & United Kingdom.
Derived failure modes
-
Unknown
The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in the intervertebral space.