Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees, Par
FDA device recall Z-1065-2025 · posted 2025-01-30 · Open, Classified
Recall details
- Recalling firm
- Alphatec Spine, Inc.
- Reason for recall
- Complaints have been received regarding post-operative implant collapse.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- MAX
- Quantity affected
- 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.
- Date initiated
- 2024-12-15
- Date posted
- 2025-01-30
- Location
- Carlsbad, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Calibrate CCX Interbody System (K232504) | Alphatec Spine, Inc. | 2023-10-13 |