Reported Nov 16, 2022 · Ongoing
Disc Preparation instruments contained in the following products: CI-11050-08102515 Longer IdentiTi PO Trial Tip, 11A X…
Alphatec Spine, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alphatec Spine, Inc. · 1950 Camino Vida Roble · Carlsbad, CA · 92008-6505
Is this the product you have?
Disc Preparation instruments contained in the following products: CI-11050-08102515 Longer IdentiTi PO Trial Tip, 11A X 8P X 10 X 25mm, 15¿
21 of 21 products
| Model / number | Barcodes | Product as published |
|---|---|---|
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 Longer Rotating Disc Shaver, Parallel, 7mm |
TC11051 | 00840180511084 | CI-11051-20-13 Longer Rotating Disc Shaver, Parallel, 13mm |
TC11051 | 00840180511145 | CI-11051-20-15 Longer Rotating Disc Shaver, Parallel, 15mm |
TC11051 | 00840180511169 | CI-11051-20-09 Longer Rotating Disc Shaver, Parallel, 9mm |
TC11051 | 00840180511107 | CI-11051-20-08 Longer Rotating Disc Shaver, Parallel, 8mm |
TC11051 | 00840180511091 | CI-11051-20-11 Longer Rotating Disc Shaver, Parallel, 11mm |
TC11051 | 00840180511121 | CI-11051-10-06 Longer Rotating Disc Shaver, Parallel, 6mm |
TC11051 | 00840180511077 | CI-11051-20-10 Longer Rotating Disc Shaver, Parallel, 10mm |
TC11051 | 00840180511114 | CI-11051-20-14 Longer Rotating Disc Shaver, Parallel, 14mm |
TC11051 | 00840180511152 | CI-11051-10-05 Longer Rotating Disc Shaver, Parallel, 5mm |
TC11051 | 00840180511060 | CI-11051-20-12 Longer Rotating Disc Shaver, Parallel, 12mm |
TC11051 | 00840180511138 | CI-11052-01-022-05 Longer Straight Curette, Size 2 |
TC11052 | 00840180511282 | CI-11052-02-022-05 Longer Up-Angled Pull Curette, Size 2 |
TC11052 | 00840180511299 | CI-11052-04-022-05 Longer Right-Angled Pull Curette, Size 2 |
TC11052 | 00840180511305 | CI-11052-05-022-05 Longer Left-Angled Curette, Size 2 |
TC11052 | 00840180511312 | CI-11071-021-05 Longer Straight Teardrop Curette, Size 2 |
- Amount recalled
- 42 devices
Where it was sold
Why it was recalled
Due to manufacturing instruments which included additional features and adequate consideration was not given to the need for a new Regulatory filing.
This product could cause temporary or reversible health problems — stop using it.
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