Calix T PEEK Lumbar System recall
Calix T PEEK Lumbar System, TLIF Rasp
Why was Calix T PEEK Lumbar System recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Calix T PEEK Lumbar System, TLIF Rasp
- Recalling firm
- X Spine Systems Inc
- Quantity
- 195 units
- Distribution
- 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.
- Recall date
- October 26, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)