Calibrate CCX Interbody System (Alphatec) – Implant Collapse Risk (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Alphatec Spine, Inc. 1950 Camino Vida Roble
Lot Codes / Batch Numbers
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, 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.
Products Sold
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.
Alphatec Spine, Inc. 1950 Camino Vida Roble is recalling Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 due to Complaints have been received regarding post-operative implant collapse.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Complaints have been received regarding post-operative implant collapse.
Recommended Action
Per FDA guidance
The recalling firm issued letters dated 12/13/2024 via email on 12/15/2024. The letter provided an attachment listing the specific device part numbers and lot numbers, the reason for recall, the potential risks, a listing of mitigating factors that should be considered when determining patient care, and field action (recall) instructions for the consignee, which included (1) Review of inventory to determine if any of the affected devices are in the consignee's possession. If the device is in the consignee's possession, the consignee is to abstain from use and contact the recalling firm immediately for return instructions; (2) Share the notice with all those who need to be aware within their organization or any organization where the affected device has been transferred; (3) Share the notice and review potential risks with doctors and surgical staff that have implanted the affected device; (4) Fill out the last page of the letter to confirm the notification has been read and the consignee has taken all necessary actions described in the notification. A revised letter dated 12/20/2024 was issued via email 12/23/2024 to update the products that were affected, as the original letter inadvertently omitted three of the part and lot numbers and also it did not indicate some of the implants were contained within convenience kits. The remainder of the letter was similar to the original letter.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026