| | Class 2 Device Recall Calix Lumbar Spinal Implant System |  |
| Date Initiated by Firm | December 19, 2018 |
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| Create Date | January 30, 2019 |
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| Recall Status1 |
Terminated 3 on April 01, 2021 |
| Recall Number | Z-0790-2019 |
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| Recall Event ID |
81899 |
| 510(K)Number | K170119 |
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| Product Classification |
Intervertebral fusion device with bone graft, lumbar - Product Code MAX
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| 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). |
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| Code Information |
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 |
| FEI Number |
3005031160
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Recalling Firm/
Manufacturer |
XTANT MEDICAL INC
664 Cruiser Ln
Belgrade MT 59714-9719
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| For Additional Information Contact | Michele Dolan
406-388-0480 Ext. 1127 |
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Manufacturer Reason
for Recall | 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. |
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FDA Determined
Cause 2 | Labeling Change Control |
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| 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). |
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| Quantity in Commerce | 632 units |
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| 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. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = MAX
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