Reported Feb 5, 2025 · Ongoing
Calibrate CCX Interbody System for spinal fusion procedures
Alphatec Spine, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alphatec Spine, Inc. · 1950 Camino Vida Roble · Carlsbad, CA · 92008-6505
Is this the product you have?
Calibrate CCX Interbody System for spinal fusion procedures
26 of 26 products
| Model / number | Product as published |
|---|---|
325-07102505 | Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees, , nonsterile |
325-07102510 | (2) Calibrate CCX-O, 7 x 10 x 25mm 10 degrees, , nonsterile |
325-07102515 | (3) Calibrate CCX-O, 7 x 10 x 25mm 15 degrees, , nonsterile |
325-07103005 | (4) Calibrate CCX-O, 7 X 10 X 30mm 5 degrees, , nonsterile |
325-07103010 | (5) Calibrate CCX-O, 7 x 10 x 30mm 10 degrees, , nonsterile |
325-07103015 | (6) Calibrate CCX-O, 7 x 10 x 30mm 15 degrees, , nonsterile |
325-07103510 | (7) Calibrate CCX-O, 7 x 10 x 35mm 10 degrees, , nonsterile |
325-07103515 | (8) Calibrate CCX-O, 7 x 10 x 35mm 15 degrees, , nonsterile |
325-09102505 | (9) Calibrate CCX-O, 9 x 10 x 25mm 5 degrees, , nonsterile |
325-09102510 | (10) Calibrate CCX-O, 9 x 10 x 25mm 10 degrees, , nonsterile |
325-09103005 | (11) Calibrate CCX-O, 9 x 10 x 30mm 5 degrees, , nonsterile |
325-09103010 | (12) Calibrate CCX-O, 9 x 10 x 30mm 10 degrees, , nonsterile |
325-11103010 | (13) Calibrate CCX-O, 11 x 10 x 30mm 10 degrees, , nonsterile |
326-07102205 | (14) Calibrate CCX-S, 7 x 10 x 22mm 5 degrees, , nonsterile |
326-07102210 | (15) Calibrate CCX-S, 7 x 10 x 22mm 10 degrees, , nonsterile |
326-07102215 | (16) Calibrate CCX-S, 7 x 10 x 22mm 15 degrees, , nonsterile |
326-07102605 | (17) Calibrate CCX-S, 7 x 10 x 26mm 5 degrees, , nonsterile |
326-07102610 | (18) Calibrate CCX-S, 7 x 10 x 26mm 10 degrees, , nonsterile |
326-07102615 | (19) Calibrate CCX-S, 7 x 10 x 26mm 15 degrees, , nonsterile |
326-07103010 | (20) Calibrate CCX-S, 7 x 10 x 30mm 10 degrees, , nonsterile |
- Lot codes and dates
28 of 28 products
Products covered by this recall # Barcodes Product as published 1 00190376533308(1) Lot numbers AP02103, AP02374, AP02426, AP02442, AP02766, AP02967, AP03207, UDI-DI 00190376533308 2 00190376532967(2) Lot numbers AP02104, AP02375, AP02427, AP02770, AP02780, AP02833, AP02834, AP02845, AP02846, AP02894, UDI-DI 00190376532967 3 00190376532974(3) Lot numbers AP02105, AP02376, AP02782, AP02893, AP02957, AP03109, AP03110, UDI-DI 00190376532974 4 00190376532998(4) Lot numbers AP02114, AP02377, AP02428, AP02429, AP02767, AP02919, UDI-DI 00190376532998 5 00190376533001(5) Lot numbers AP02106, AP02263, AP02378, AP02430, AP02771, AP02783, AP02836, AP02837, AP02838, AP02839, UDI-DI 00190376533001 6 00190376533018(6) Lot numbers AP02107, AP02379, AP02431, AP02781, AP02835, AP02847, AP02848, AP02892. UDI-DI 00190376533018 7 00190376533049(7) Lot numbers AP02108, AP02380, AP02432, AP02433, UDI-DI 00190376533049 8 00190376533056(8) Lot number AP02144, UDI-DI 00190376533056 9 00190376533322(9) Lot numbers AP02109, AP02257, AP02381, AP02434, AP02435, AP02436, AP02768, AP03180, UDI-DI 00190376533322 10 00190376533339(10) Lot numbers AP02110, AP02382, AP02772, AP02962, UDI-DI 00190376533339 11 00190376533360(11) Lot numbers AP02111, AP02259, AP02383, AP02437, AP02438, UDI-DI 00190376533360 12 00190376533377(12) Lot numbers AP02112, AP02384, AP02626, AP02711, AP02773, UDI-DI 00190376533377 13 00190376532653(13) Lot numbers AP02113, AP02385, AP02439, AP02440, AP02441, AP02774, AP02921, UDI-DI 00190376532653 14 00190376530277(14) Lot numbers AP02115, AP02258, AP02283, AP02301, AP02710, AP02925, AP02971, AP03100, UDI-DI 00190376530277 15 00190376530284(15) Lot numbers AP02116, AP02302, AP02871, AP02872, AP02896, UDI-DI 00190376530284 16 00190376530291(16) Lot numbers AP02117, AP02303, AP02623, UDI-DI 00190376530291 17 00190376530314(17) Lot numbers AP02118, AP02304, AP02775, AP02869, AP02875, UDI-DI 00190376530314 18 00190376530321(18) Lot numbers AP02119, AP02305, AP02422, AP02777, AP02785, AP02843, UDI-DI 00190376530321 19 00190376530338(19) Lot numbers AP02120, AP02306, AP02624, AP02744, AP02895, AP02922, UDI-DI 00190376530338 20 00190376530369(20) Lot numbers AP02121, AP02307, AP02423, UDI-DI 00190376530369 - Amount recalled
- 1,127 loose implants; 10/24-implant kits; and 4/36-implant kits (1,511 total implants)
Where it was sold
Why it was recalled
Complaints have been received regarding post-operative implant collapse.
This product could cause temporary or reversible health problems — stop using it.
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