Recall
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…
Alphatec Spine, Inc. · 14 Sept 2022
- Status
- Recall open, classified
- Why, in the FDA's words
- “Due to manufacturing instruments which included additional features and adequate consideration was not given to the need for a new Regulatory filing.”
- Recall began
- 14 Sept 2022
- Company
- Alphatec Spine, Inc.
- Device type
- Orthopedic stereotaxic instruments (knee, hip and spine robots) (OLO)
What it means
A recall is the FDA's record that a company is correcting or removing a device because of a problem. Many are fixed with a software update or new instructions; the record does not say whether anyone was hurt. See our plain guide to FDA terms.
The record
The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.