Device recall
Z-0196-2023: Disc Preparation instruments contained in the following products…
FDA device recall · Class II · Alphatec Spine, Inc.
Key facts
| Recall number (Z-number) | Z-0196-2023 |
|---|---|
| Recall event | 90940 |
| 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… |
| Product code | OLO |
| Recalling firm | Alphatec Spine, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 2027467 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database