FDA Medical Device Recalls (openFDA)
X Spine Systems Inc: Calix P PEEK Lumbar System, PLIF Rasp
- Recall number
- Z-0124-2017
- Recalling firm
- X Spine Systems Inc
- Product
- Calix P PEEK Lumbar System, PLIF Rasp
- Status
- Terminated
- Initiated
- 2016-05-17
- Posted
- not on file
- Terminated
- 2019-04-04
- 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.
- Root cause
- Component design/selection
- Action
- Consignees will be notified via email and courier and will be instructed to return the affected product. Upon receipt of the recalled trays, the trials and rasps will be removed from the tray and quarantined for evenutal destruction.
- Quantity
- 182 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K131350"]
- PMA numbers
- not on file
- Product code
- MAX
- Firm FEI
- 3005031160
- Firm city
- Miamisburg
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28