Class 2 Device Recall Alphatec

• Date Initiated by Firm: December 15, 2024
• Date Posted: January 30, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1065-2025
• Recall Event ID: 96009
• 510(K)Number: K232504
• Product Classification: Intervertebral fusion device with bone graft, lumbar - Product Code MAX
• 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.
• Code Information: 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.
• Recalling Firm/ Manufacturer: Alphatec Spine, Inc.; 1950 Camino Vida Roble; Carlsbad CA 92008-6505
• For Additional Information Contact: Customer Service Team; 800-922-1356
• Manufacturer Reason for Recall: Complaints have been received regarding post-operative implant collapse.
• FDA Determined Cause: Under Investigation by firm
• Action: 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.
• Quantity in Commerce: 1,127 loose implants; 10/24-implant kits; and 4/36-implant kits (1,511 total implants)
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MAX