Calibrate CCX Interbody System for spinal fusion procedures: Implants: — Class II medical device recall Z-1065-2025

Ongoing recall by Alphatec Spine, Inc., reported 2025-02-05, distributed nationwide. Complaints have been received regarding post-operative implant collapse.

Recall number	`Z-1065-2025`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Alphatec Spine, Inc., Carlsbad, CA, United States
Recall initiated	2024-12-15
Classified	2025-01-30
Reported by FDA	2025-02-05
Distributed	Nationwide (US)
UPC / GTIN / UDI-DI	`00190376530277`, `00190376530284`, `00190376530291`, `00190376530314`, `00190376530321`, `00190376530338`, `00190376530369`, `00190376530758`, `00190376530765`, `00190376530796`, `00190376530802`, `00190376531281`, `00190376532653`, `00190376532967`, `00190376532974`, `00190376532998`, `00190376533001`, `00190376533018`, `00190376533049`, `00190376533056`, `00190376533308`, `00190376533322`, `00190376533339`, `00190376533360`, `00190376533377` and 2 more
Lot numbers	`AP02103`, `AP02104`, `AP02105`, `AP02106`, `AP02107`, `AP02108`, `AP02109`, `AP02110`, `AP02111`, `AP02112`, `AP02113`, `AP02114`, `AP02115`, `AP02116`, `AP02117`, `AP02118`, `AP02119`, `AP02120`, `AP02121`, `AP02122`, `AP02123`, `AP02124`, `AP02125`, `AP02126`, `AP02144`, `AP02257`, `AP02258`, `AP02259`, `AP02263`, `AP02283`, `AP02301`, `AP02302`, `AP02303`, `AP02304`, `AP02305`, `AP02306`, `AP02307`, `AP02308`, `AP02309`, `AP02310` and 102 more
Serial numbers	`2000494`, `2000495`, `2000496`, `2000497`, `2000498`, `2000499`, `2000500`, `2000501`, `2000502`, `2000503`, `2000727`, `2000728`, `2000730`, `2000731`
Model numbers	`325-07102505`, `325-07102510`, `325-07102515`, `325-07103005`, `325-07103010`, `325-07103015`, `325-07103510`, `325-07103515`, `325-09102505`, `325-09102510`, `325-09103005`, `325-09103010`, `325-11103010`, `326-07102205`, `326-07102210`, `326-07102215`, `326-07102605`, `326-07102610`, `326-07102615`, `326-07103010`, `326-09102205`, `326-09102210`, `326-09102605`, `326-09102610`, `326-11102610`

Product

Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees, Part #325-07102505, nonsterile; (2) Calibrate CCX-O, 7 x 10 x 25mm 10 degrees, Part #325-07102510, nonsterile; (3) Calibrate CCX-O, 7 x 10 x 25mm 15 degrees, Part #325-07102515, nonsterile; (4) Calibrate CCX-O, 7 X 10 X 30mm 5 degrees, Part #325-07103005, nonsterile; (5) Calibrate CCX-O, 7 x 10 x 30mm 10 degrees, Part #325-07103010, nonsterile; (6) Calibrate CCX-O, 7 x 10 x 30mm 15 degrees, Part #325-07103015, nonsterile; (7) Calibrate CCX-O, 7 x 10 x 35mm 10 degrees, Part #325-07103510, nonsterile; (8) Calibrate CCX-O, 7 x 10 x 35mm 15 degrees, Part #325-07103515, nonsterile; (9) Calibrate CCX-O, 9 x 10 x 25mm 5 degrees, Part #325-09102505, nonsterile; (10) Calibrate CCX-O, 9 x 10 x 25mm 10 degrees, Part #325-09102510, nonsterile; (11) Calibrate CCX-O, 9 x 10 x 30mm 5 degrees, Part #325-09103005, nonsterile; (12) Calibrate CCX-O, 9 x 10 x 30mm 10 degrees, Part #325-09103010, nonsterile; (13) Calibrate CCX-O, 11 x 10 x 30mm 10 degrees, Part #325-11103010, nonsterile; (14) Calibrate CCX-S, 7 x 10 x 22mm 5 degrees, Part #326-07102205, nonsterile; (15) Calibrate CCX-S, 7 x 10 x 22mm 10 degrees, Part #326-07102210, nonsterile; (16) Calibrate CCX-S, 7 x 10 x 22mm 15 degrees, Part #326-07102215, nonsterile; (17) Calibrate CCX-S, 7 x 10 x 26mm 5 degrees, Part #326-07102605, nonsterile; (18) Calibrate CCX-S, 7 x 10 x 26mm 10 degrees, Part #326-07102610, nonsterile; (19) Calibrate CCX-S, 7 x 10 x 26mm 15 degrees, Part #326-07102615, nonsterile; (20) Calibrate CCX-S, 7 x 10 x 30mm 10 degrees, Part #326-07103010, nonsterile; (21) Calibrate CCX-S, 9 x 10 x 22mm 5 degrees, Part #326-09102205, nonsterile; (22) Calibrate CCX-S, 9 x 10 x 22mm 10 degrees, Part #326-09102210, nonsterile; (23) Calibrate CCX-S, 9 x 10 x 26mm 5 degrees, Part #326-09102605, nonsterile; (24) Calibrate CCX-S, 9 x 10 x 26mm 10 degrees, Part #326-09102610, nonsterile; and (25) Calibrate CCX-S, 11 x 10 x 26mm 10 degrees, Part #326-11102610, nonsterile. Convenience kits containing affected implants: (1) Calibrate CCX Oblique Implants, REF CLCCXOIMPA, containing 24 implants/kit, nonsterile; and (2) Calibrate CCX Straight Implants, REF CLCCXSIMPA, containing 36 implants/kit, nonsterile.

Reason for recall

Complaints have been received regarding post-operative implant collapse.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1065-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.