Z-0126-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 26, 2016
- Initiation Date
- May 17, 2016
- Termination Date
- April 4, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 195 units
Product Description
Calix T PEEK Lumbar System, TLIF Rasp
Reason for Recall
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.
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.
Code Information
Size, 28mm x 10mm x 6mm, Part #:, X034-0360, Lot #:, 23515, 23516, 24295, 24836, 24836s1, 24836S2, 657001, 760913 & Size, 28mm x 10mm x 10mm, Part #:, X034-0364, Lot #:, 23517, 23518, 24296, 24837, 657002, 760914.