Class II — Alphatec Spine, Inc.
| Recalling firm | ALPHATEC HOLDINGS, INC. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to manufacturing instruments which included additional features and adequate consideration was not given to the need for a new Regulatory filing. |
| Product | Disc Preparation instruments contained in the following products: 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 CI-11051-10-07 … |
| Quantity | 42 devices |
| Distribution | U.S.: CA O.U.S.: N/A |
| Initiated | 2022-09-14 |
| Classified | 2022-11-07 |
| Recall number | Z-0196-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Alphatec Spine, Inc. (Z-0196-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90940/
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