XTANT MEDICAL INC: Calix Lumbar Spinal Implant System: 22mm x 10mm x 7mm PLIF ASSY PC, REF X034-0172PC 22mm x 10mm x 8mm PLIF ASSY PC, REF X034-0173PC 26mm x 10mm x 6mm PLIF ASSY PC, REF X034-0240PC 26mm x 10mm x 8mm PLIF ASSY PC, REF X034-0241PC 26mm x 10mm x 10mm PLIF ASSY PC, REF X034-0242PC 26mm x 10mm x 12mm PLIF ASSY PC, REF X034-0243PC 26mm x 10mm x 6mm TLIF ASSY PC, REF X034-0280PC 28mm x 10mm x 7mm TLIF ASSY PC, REF X034-0281PC 28mm x 10mm x 8mm TLIF ASSY PC, REF X034-0282PC 28mm x 10mm x 9mm TLIF ASSY PC, REF X034-0283PC 28mm x 10mm x 10mm TLIF ASSY PC, REF X034-0284PC 28mm x 10mm x 11mm TLIF ASSY PC, REF X034-0285PC 28mm x 10mm x 12mm TLIF ASSY PC, REF X034-0286PC 28mm x 10mm x 13mm TLIF ASSY PC, REF X034-0287PC 28mm x 10mm x 14mm TLIF ASSY PC, REF X034-0288PC 28mm x 10mm x 15mm TLIF ASSY PC, REF X034-0289PC 28mm x 10mm x 16mm TLIF ASSY PC, REF X034-0290PC 26mm x 10mm x 6mm 5o PLIF Assy PC, REF X034-0387PC 26mm x 10mm x 7mm 5o PLIF Assy PC, REF X034-0388PC 26mm x 10mm x 8mm 5o PLIF Assy PC, REF X034-0389PC 26mm x 10mm x 9mm 5o PLIF Assy PC, REF X034-0390PC 26mm x 10mm x 10mm 5o PLIF Assy PC, REF X034-0391PC 26mm x 10mm x 11mm 5o PLIF Assy PC, REF X034-0392PC 26mm x 10mm x 12mm 5o PLIF Assy PC, REF X034-0393PC 26mm x 10mm x 13mm 5o PLIF Assy PC, REF X034-0394PC 26mm x 10mm x 14mm 5o PLIF Assy PC, REF X034-0395PC 26mm x 10mm x 15mm 5o PLIF Assy PC, REF X034-0396PC This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

Recall number

Z-0790-2019

Recalling firm

XTANT MEDICAL INC

Product

Calix Lumbar Spinal Implant System: 22mm x 10mm x 7mm PLIF ASSY PC, REF X034-0172PC 22mm x 10mm x 8mm PLIF ASSY PC, REF X034-0173PC 26mm x 10mm x 6mm PLIF ASSY PC, REF X034-0240PC 26mm x 10mm x 8mm PLIF ASSY PC, REF X034-0241PC 26mm x 10mm x 10mm PLIF ASSY PC, REF X034-0242PC 26mm x 10mm x 12mm PLIF ASSY PC, REF X034-0243PC 26mm x 10mm x 6mm TLIF ASSY PC, REF X034-0280PC 28mm x 10mm x 7mm TLIF ASSY PC, REF X034-0281PC 28mm x 10mm x 8mm TLIF ASSY PC, REF X034-0282PC 28mm x 10mm x 9mm TLIF ASSY PC, REF X034-0283PC 28mm x 10mm x 10mm TLIF ASSY PC, REF X034-0284PC 28mm x 10mm x 11mm TLIF ASSY PC, REF X034-0285PC 28mm x 10mm x 12mm TLIF ASSY PC, REF X034-0286PC 28mm x 10mm x 13mm TLIF ASSY PC, REF X034-0287PC 28mm x 10mm x 14mm TLIF ASSY PC, REF X034-0288PC 28mm x 10mm x 15mm TLIF ASSY PC, REF X034-0289PC 28mm x 10mm x 16mm TLIF ASSY PC, REF X034-0290PC 26mm x 10mm x 6mm 5o PLIF Assy PC, REF X034-0387PC 26mm x 10mm x 7mm 5o PLIF Assy PC, REF X034-0388PC 26mm x 10mm x 8mm 5o PLIF Assy PC, REF X034-0389PC 26mm x 10mm x 9mm 5o PLIF Assy PC, REF X034-0390PC 26mm x 10mm x 10mm 5o PLIF Assy PC, REF X034-0391PC 26mm x 10mm x 11mm 5o PLIF Assy PC, REF X034-0392PC 26mm x 10mm x 12mm 5o PLIF Assy PC, REF X034-0393PC 26mm x 10mm x 13mm 5o PLIF Assy PC, REF X034-0394PC 26mm x 10mm x 14mm 5o PLIF Assy PC, REF X034-0395PC 26mm x 10mm x 15mm 5o PLIF Assy PC, REF X034-0396PC This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

Status

Terminated

Initiated

2018-12-19

Posted

not on file

Terminated

2021-04-01

Reason

This recall has been initiated due to a change in packaging and sterilization method to address potential risks of compromised sterilization presented by the existing configuration.

Root cause

Labeling Change Control

Action

The firm, Xtant Medical, sent an "URGENT: VOLUNTARY MEDICAL DEVICE RECALL" letter dated 12/14/2018 on 12/19/2018 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to: Immediately examine your inventory and quarantine product subject to recall. In addition, if you have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Complete and return the enclosed tracking/verification form (even if you do not have any implants to return) as soon as possible by mail: ATTN: CALIX, Xtant Medical, Inc., 732 Cruiser Lane, Belgrade, MT 59714, email: tkarlberg@xtantmedical.com or fax to:1-406-388-3380. If product(s) is (are) located, please email: tkarlberg@xtantmedical.com or call 1-888-886-9354 ext. 131 from 8 a.m. to 5 p.m. (Mountain Standard Time) to obtain Instructions for returning the affected product to Xtant at no cost to you. If you have any questions, call Casey Ming, 1-888-886-9354 ext. 1128 from 8 a.m. to 5 p.m. (Mountain Standard Time).

Quantity

632 units

Distribution

US Distribution in states of: AZ, CA, CO, FL, IN, LA, MS, GA, KA, MI, NV, WV, TX, and internationally to: Australia, Mexico, Portugal, UK, and Italy.

Lot, serial or model codes

UPC/UDI/Lot numbers REF X034-0172PC, M697X0340172PC1 19211-2, 21017-1 REF X034-0173PC, M697X0340173PC1 041790, 17075-5, 17196-3 REF X034-0240PC, M697X0340240PC1 042050, 18890-1, 20745-1, 17196-12, 18216-1 REF X034-0241PC, M697X0340241PC1 039171, 042071, 054614, 056529, 057161, 058525, 17196-13, 20745-2  REF X034-0242PC, M697X0340242PC1 20962, 054621, 055442, 058526, 20745-3 REF X034-0243PC, M697X0340243PC1 042073, 054624, 058527, 16730-15, 17075-16, 17196-15,18216-4, 19212-4, 20745-4  REF X034-0280PC, M697X0340280PC1 043764, 062836, 063476, 065284, 040738PC, 19626-1, 19903-1, 20164-1, 20774-1 REF X034-0281PC, M697X0340281PC1 040746PC, 043852, 054531, 055202, 055436, 055742, 056756, 059809, 061983, 062837, 17304-2, 19903-2, 19212-7, 19626-2, 19891-1, 20164-2, 20774-2, 21269-2  REF X034-0282PC, M697X0340282PC1 040757PC, 043765, 054532, 054539, 055203, 055437, 055745, 056757, 059810, 062080, 062838, 063529, 19212-8, 19626-3, 19742-3 19903-1, 19903-3,20164-3, 20774-3,  REF X034-0283PC, M697X0340283PC1 040759PC, 043853, 054370, 054540, 055204, 055438, 055746, 056758, 059811, 062081, 062839, 064312, 19212-9, 19626-4, 19742-4, 19903-4, 20462-3, 20774-4, 20164-4, 21269-3  REF X034-0284PC, M697X0340284PC1 040758PC, 043854, 054399, 054541, 055205, 055439, 055747, 056759, 059812, 062082, 19147-8A, 19903-5, 19212-10, 19626-5, 19742-5, 20164-5, 20462-4A  REF X034-0285PC, M697X0340285PC1 040761PC, 043855, 054401, 055206, 054542, 055206, 055440, 055748, 056760, 059821, 19147-10, 19626-6, 20164-6 REF X034-0286PC, M697X0340286PC1 055441, 055749, 059822, 040809PC, 17304-7, 19212-12, 19626-7, 19742-7, 19903-7, 20164-7, 20462-5 REF X034-0287PC, M697X0340287PC1 040937PC, 19147-4, 19217-1, 19742-8, 20164-8, 20462-6 REF X034-0288PC, M697X0340288PC1 043856, 040810PC, 19147-5, 19147-5A, 19217-2, 19742-9, 19903-9 REF X034-0289PC, M697X0340289PC1 040938, 040938PC, 19147-6, 19217-3, 19147-6A, 19742-10, 20164-10  REF X034-0290PC, M697X0340290PC1 040745, 043859, 17304-11, 17304-11PC, 18574-7, 19147-11, 19147-11A, 19217-4, 19903-11, 20164-11 REF X034-0387PC, M697X0340387PC1 039775, 041928, 17075-4, 19217-5, 20745-5 REF X034-0388PC, M697X0340388PC1 055534, 061988, 18607-2, 19058, 20590-9, 20745-6 REF X034-0389PC, M697X0340389PC1 041929, 055443, 056752, 059802, 17075-18, 18861-8, 19217-6, 20745-7, 21273-2 REF X034-0390PC, M697X0340390PC1 054837, 055207, 055444, 055543, 055544, 056753, 059805, 063120, 19217-7, 18007-4, 18567-3, 20745-8 REF X034-0391PC, M697X0340391PC1 054403, 054626, 055208, 055446, 055544, 059806, 063121, 20745-9 REF X034-0392PC, M697X0340392PC1 054413, 054627, 055209, 055447, 055545, 056754, 063122, 17591-5, 18007-5, 18889-5, 18890-520590-10, 20745-10 REF X034-0393PC, M697X0340393PC1 038451, 038567, 054407, 054928, 055210, 055448, 055547, 056755, 20745-11, 21273-3 REF X034-0394PC, M697X0340394PC1 055211, 055449, 055548, 061987, 064315, 17756, 18007-6, 18890-6, 20590-5, 20745-12 REF X034-0395PC, M697X0340395PC1 16730-21, 19374-7, 17075-21, 20745-13, 21017-4 REF X034-0396PC, M697X0340396PC1 059807, 17591-6, 18890-7, 20745-14

510(k) numbers

["K170119"]

PMA numbers

not on file

Product code

MAX

Firm FEI

3005031160

Firm city

Belgrade

Firm state

MT

Firm country

not on file

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

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