Recall archive / FDA device enforcement

Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees, ... — FDA record Z-1065-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Dec 15, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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: Complaints have been received regarding post-operative implant collapse.
Classification: Class II
Recalling firm: Alphatec Spine, Inc.
Quantity: 1,127 loose implants; 10/24-implant kits; and 4/36-implant kits (1,511 total implants)
Agency-reported status: Ongoing
Source record identifier: Z-1065-2025

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Implants: (1) Lot numbers AP02103, AP02374, AP02426, AP02442, AP02766, AP02967, AP03207, UDI-DI 00190376533308; (2) Lot numbers AP02104, AP02375, AP02427, AP02770, AP02780, AP02833, AP02834, AP02845, AP02846, AP02894, UDI-DI 00190376532967; (3) Lot numbers AP02105, AP02376, AP02782, AP02893, AP02957, AP03109, AP03110, UDI-DI 00190376532974; (4) Lot numbers AP02114, AP02377, AP02428, AP02429, AP02767, AP02919, UDI-DI 00190376532998; (5) Lot numbers AP02106, AP02263, AP02378, AP02430, AP02771, AP02783, AP02836, AP02837, AP02838, AP02839, UDI-DI 00190376533001; (6) Lot numbers AP02107, AP02379, AP02431, AP02781, AP02835, AP02847, AP02848, AP02892. UDI-DI 00190376533018; (7) Lot numbers AP02108, AP02380, AP02432, AP02433, UDI-DI 00190376533049; (8) Lot number AP02144, UDI-DI 00190376533056; (9) Lot numbers AP02109, AP02257, AP02381, AP02434, AP02435, AP02436, AP02768, AP03180, UDI-DI 00190376533322; (10) Lot numbers AP02110, AP02382, AP02772, AP02962, UDI-DI 00190376533339; (11) Lot numbers AP02111, AP02259, AP02383, AP02437, AP02438, UDI-DI 00190376533360; (12) Lot numbers AP02112, AP02384, AP02626, AP02711, AP02773, UDI-DI 00190376533377; (13) Lot numbers AP02113, AP02385, AP02439, AP02440, AP02441, AP02774, AP02921, UDI-DI 00190376532653; (14) Lot numbers AP02115, AP02258, AP02283, AP02301, AP02710, AP02925, AP02971, AP03100, UDI-DI 00190376530277; (15) Lot numbers AP02116, AP02302, AP02871, AP02872, AP02896, UDI-DI 00190376530284; (16) Lot numbers AP02117, AP02303, AP02623, UDI-DI 00190376530291; (17) Lot numbers AP02118, AP02304, AP02775, AP02869, AP02875, UDI-DI 00190376530314; (18) Lot numbers AP02119, AP02305, AP02422, AP02777, AP02785, AP02843, UDI-DI 00190376530321; (19) Lot numbers AP02120, AP02306, AP02624, AP02744, AP02895, AP02922, UDI-DI 00190376530338; (20) Lot numbers AP02121, AP02307, AP02423, UDI-DI 00190376530369; (21) Lot numbers AP02122, AP02312, AP02424, UDI-DI 00190376530758; (22) Lot numbers AP02123, AP02306, AP02308, AP02625, UDI-DI 00190376530765; (23) Lot numbers AP02124, AP02309, AP02425, AP02776, AP02786, AP02844, UDI-DI 00190376530796; (24) Lot numbers AP02125, AP02310, AP02778, AP02784, AP02840, AP02841, AP02842, AP02870, AP03095, UDI-DI 00190376530802; and (25) Lot numbers AP02126, AP02311, AP02779, UDI-DI 00190376531281. Convenience kits containing affected implants: (1) REF CLCCXOIMPA - Serial numbers 2000494, 2000495, 2000496, 2000497, 2000498, 2000499, 2000500, 2000501, 2000502, and 2000503; UDI-DI 00190376553535; and (2) REF CLCCXSIMPA - Serial numbers 2000727, 2000728, 2000730, and 2000731; UDI-DI 00190376553542.

Label field

Details supplied by the agency

Lot, code or applicability

Implants: (1) Lot numbers AP02103, AP02374, AP02426, AP02442, AP02766, AP02967, AP03207, UDI-DI 00190376533308; (2) Lot numbers AP02104, AP02375, AP02427, AP02770, AP02780, AP02833, AP02834, AP02845, AP02846, AP02894, UDI-DI 00190376532967; (3) Lot numbers AP02105, AP02376, AP02782, AP02893, AP02957, AP03109, AP03110, UDI-DI 00190376532974; (4) Lot numbers AP02114, AP02377, AP02428, AP02429, AP02767, AP02919, UDI-DI 00190376532998; (5) Lot numbers AP02106, AP02263, AP02378, AP02430, AP02771, AP02783, AP02836, AP02837, AP02838, AP02839, UDI-DI 00190376533001; (6) Lot numbers AP02107, AP02379, AP02431, AP02781, AP02835, AP02847, AP02848, AP02892. UDI-DI 00190376533018; (7) Lot numbers AP02108, AP02380, AP02432, AP02433, UDI-DI 00190376533049; (8) Lot number AP02144, UDI-DI 00190376533056; (9) Lot numbers AP02109, AP02257, AP02381, AP02434, AP02435, AP02436, AP02768, AP03180, UDI-DI 00190376533322; (10) Lot numbers AP02110, AP02382, AP02772, AP02962, UDI-DI 00190376533339; (11) Lot numbers AP02111, AP02259, AP02383, AP02437, AP02438, UDI-DI 00190376533360; (12) Lot numbers AP02112, AP02384, AP02626, AP02711, AP02773, UDI-DI 00190376533377; (13) Lot numbers AP02113, AP02385, AP02439, AP02440, AP02441, AP02774, AP02921, UDI-DI 00190376532653; (14) Lot numbers AP02115, AP02258, AP02283, AP02301, AP02710, AP02925, AP02971, AP03100, UDI-DI 00190376530277; (15) Lot numbers AP02116, AP02302, AP02871, AP02872, AP02896, UDI-DI 00190376530284; (16) Lot numbers AP02117, AP02303, AP02623, UDI-DI 00190376530291; (17) Lot numbers AP02118, AP02304, AP02775, AP02869, AP02875, UDI-DI 00190376530314; (18) Lot numbers AP02119, AP02305, AP02422, AP02777, AP02785, AP02843, UDI-DI 00190376530321; (19) Lot numbers AP02120, AP02306, AP02624, AP02744, AP02895, AP02922, UDI-DI 00190376530338; (20) Lot numbers AP02121, AP02307, AP02423, UDI-DI 00190376530369; (21) Lot numbers AP02122, AP02312, AP02424, UDI-DI 00190376530758; (22) Lot numbers AP02123, AP02306, AP02308, AP02625, UDI-DI 00190376530765; (23) Lot numbers AP02124, AP02309, AP02425, AP02776, AP02786, AP02844, UDI-DI 00190376530796; (24) Lot numbers AP02125, AP02310, AP02778, AP02784, AP02840, AP02841, AP02842, AP02870, AP03095, UDI-DI 00190376530802; and (25) Lot numbers AP02126, AP02311, AP02779, UDI-DI 00190376531281. Convenience kits containing affected implants: (1) REF CLCCXOIMPA - Serial numbers 2000494, 2000495, 2000496, 2000497, 2000498, 2000499, 2000500, 2000501, 2000502, and 2000503; UDI-DI 00190376553535; and (2) REF CLCCXSIMPA - Serial numbers 2000727, 2000728, 2000730, and 2000731; UDI-DI 00190376553542.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IA, IL, IN, MA, MD, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SC, SD, TN, and UT.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Feb 5, 2025
Recall initiation date: Dec 15, 2024
Center classification date: Jan 30, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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