X Spine Systems Inc: Medical Device Recall in 2016 - (Recall #: Z-0125-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Calix P PEEK Lumbar System, PLIF Trial

Product Classification:

Class II

Date Initiated: May 17, 2016

Date Posted: October 26, 2016

Recall Number: Z-0125-2017

Event ID: 74397

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.

Status: Terminated

Product Quantity: 1504 units

Code Information:

Size, 22mm x 10mm x 6mm, Part #:, X034-0970, Lot #:, 015857-6-1, 021425, 025070, 28221, 31896, 656802; Size, 22mm x 10mm x 7mm, Part #:, X034-0971, Lot #:, 015857-6-1, 021425, 025070, 28221, 31896, 656802; Size, 22mm x 10mm x 8mm, Part #:, X034-0972, Lot #:, 015857-7-1, 021426, 025071, 28224, 656803; Size, 22mm x 10mm x 9mm, Part #:, X034-0973, Lot #:, 015857-8-1, 021427, 025072, 28225, 28225R, 656804; Size, 22mm x 10mm x 10mm , Part #:, X034-0974, Lot #:, 015857-9-1, 021428, 025073, 28226, 656805; Size, 22mm x 10mm x 11mm, Part #:, X034-0975, Lot #:, 015857-10-1, 021429, 025074, 28227, 656806; Size, 22mm x 10mm x 12mm, Part #:, X034-0976, Lot #:, 015857-11-1, 021430, 025075, 28228, 656807; Size, 22mm x 10mm x 13mm, Part #:, X034-0977, Lot #:, 015857-12-1, 021432, 025076, 28229, 656808; Size, 22mm x 10mm x 14mm, Part #:, X034-0978, Lot #:, 015857-13-1,021433, 025077,125077, 28230, 656809; Size, 22mm x 10mm x 15mm, Part #:, X034-0979, Lot #:, 656810, 015857-13, 21434, 25078, 28231; Size, 22mm x 10mm x 16mm, Part #:, X034-0980, Lot #:, 015857-15-1, 015857-16-1, 021435, 021436, 025079, 28232, 656811; Size, 26mm x 10mm x 6mm, Part #:, X034-1050, Lot #:, 015857-15-1, 015857-16-1, 021435, 021436, 025079, 28232, 656811; Size, 26mm x 10mm x 8mm, Part #:, X034-1052, Lot #:, 015857-19-1, 021439, 025081, 10346, 26234, 28234, 656813, 656813R; Size, 26mm x 10mm x 9mm, Part #:, X034-1053, Lot #:, 10121, 11947; Size, 26mm x 10mm x 10mm, Part #:, X034-1054, Lot #:, 015857-20-1, 021440, 025082, 28235, 656814; Size, 26mm x 10mm x 11mm, Part #:, X034-1055, Lot #:, 10124, 11948; Size, 26mm x 10mm x 12mm, Part #:, X034-1056, Lot #:, 015857-21-1, 021441, 025083, 28236, 656815; Size, 26mm x 10mm x 13mm, Part #:, X034-1057, Lot #:, 10125, 11949 & Size, 26mm x 10mm x 14mm, Part #:, X034-1058, Lot #:, 021443, 015857-22-1, 015857-23-1, 021442, 021443, 025084, 28237, 656816.

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.

Voluntary or Mandated:

Voluntary: Firm initiated