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Open, Classified

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.

FDA Recall Z-1065-2025 · Posted 2025-01-30

Recalling FirmAlphatec Spine, Inc.
Recall StatusOpen, Classified
Product CodeMAX
Date Initiated2024-12-15
Product Quantity1,127 loose implants; 10/24-implant kits; and 4/36-implant kits (1,511 total implants)

Reason for Recall

Complaints have been received regarding post-operative implant collapse.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc. · 2023-10-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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