medical Class II Updated 2025-02-05

Alphatec Spine, Inc. recalls Calibrate CCX Interbody System for spinal fusion procedures:

Recalled 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.

Hazard / Issue

Complaints have been received regarding post-operative implant collapse.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: 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.

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