Alphatec Calibrate CCX Interbody Implants Recalled for Post-Operative Collapse
Alphatec Spine is recalling Calibrate CCX spinal implants used in fusion procedures after receiving complaints of post-operative implant collapse. Approximately 1,511 implants were distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall for a high-risk spinal implant with received complaints of post-operative collapse. The complaints indicate actual adverse events rather than theoretical risk, but the source does not provide explicit hospitalization counts or detailed injury severity data.
Plain-English summary
Alphatec Spine, Inc. is recalling the Calibrate CCX Interbody System, a spinal fusion device consisting of multiple implant models and sizes used in back surgery. The recall involves approximately 1,511 total implants, including 1,127 loose implants and 14 convenience kits.
The manufacturer issued this recall following complaints of post-operative implant collapse. Implant collapse after surgery can require additional medical intervention and corrective procedures. The affected implants were distributed nationwide to Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, and Utah.
Patients who have received these implants should contact their surgeon or healthcare provider with any concerns related to their implant. Healthcare providers can identify affected implants using the specific lot numbers and part numbers detailed in the FDA recall notice.
The recalled product
- 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 d
- Manufacturer
- Alphatec Spine, Inc.
- Category
- Medical Device — Spinal Implant
- Hazard
- implant-collapse
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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