Alphatec recalls specific disc preparation instruments due to manufacturing issues that may require regulatory filing. Check product details to see if your item is affected.
“Alphatec Disc Preparation Instruments Recall: Manufacturing Issue.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60065-alphatec-disc-preparation-instruments-recall-manufacturing-issue. Based on FDA recall #Z-0196-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0196-2023%22&limit=1).
The FDA announced on 2022-09-14 that Alphatec Spine, Inc. is recalling Disc Preparation instruments due to manufacturing issues where additional features were included without adequate regulatory consideration. The agency issued recall number Z-0196-2023 for the voluntary Class II recall.
How to tell if you have it
CI-11050-08102515 Longer IdentiTi PO Trial Tip, 11A X 8P X 10 X 25mm, 15¿ TC11050 00840180510810
CI-11050-09102515 Longer IdentiTi PO Trial Tip, 12A X 9P X 10 X 25mm, 15¿ TC11050 00840180510827
CI-11050-10102515 Longer IdentiTi PO Trial Tip, 13A X 10P X 10 X 25mm, 15¿ TC11050 00840180510834
CI-11050-11102515 Longer IdentiTi PO Trial Tip, 14A X 11P X 10 X 25mm, 15¿ TC11050 00840180510841
CI-11050-12102515 Longer IdentiTi PO Trial Tip, 15A X 12P X 10 X 25mm, 15¿ TC11050 00840180510858
The recall involves Disc Preparation instruments that included additional features for which adequate consideration was not given to the need for a new Regulatory filing. The FDA said the manufacturing process resulted in these non-compliant devices.
Context
GovInfoNow's records show Alphatec Spine, Inc. has 6 other recalls on record since 2021-04-26. Recent brand recalls include a 2026-05-13 SafeOp Patient Interface Software Issue and a 2026-01-02 LIF NAV Osteotome 10mm navigation geometry risk. Other recent recalls of similar products include a 2026-04-27 Becton Dickinson Spinal Tray Recall, a 2026-04-27 Windstone Aligned Medical AMS16835 Fluids Kit Recall, and a 2026-02-27 Medline Convenience Kits with Unapproved Syringes Recall.
How to tell if you have this one
Check for product names like 'Longer IdentiTi PO Trial Tip' or 'Longer Rotating Disc Shaver' with specific model numbers listed in the recall notice. The recall includes items with TC11050, TC11051, or TC11052 part numbers.
Brand
Alphatec
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Review the product names and model numbers listed in the recall notice to determine if your instrument is affected.
Where it went and when
Where it was distributed
Distributed in California.
Listed by the agency
Not listed
FDA distribution: “U.S.: CA O.U.S.: N/A” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0196-2023 (September 14, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0196-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.