Calix P PEEK Lumbar System, PLIF Trial
This recall has been terminated (originally issued May 17, 2016).
- Company
- X Spine Systems Inc
- Recall Initiated
- May 17, 2016
- Terminated
- April 4, 2019
- Recall Number
- Z-0125-2017
- Quantity
- 1504 units
- Firm Location
- Miamisburg, OH
- Official Source
- View on FDA website ↗
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
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 / Code Info
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.
Root Cause
Component design/selection
Action Taken
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.