Recall Z-0196-2023 ยท OLO Orthopedic Stereotaxic Instrument
Alphatec Spine, Inc.
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
| Date | Nov 8, 2022 (initiated Sep 14, 2022) |
| Status | Open, Classified |
| Reason | Due to manufacturing instruments which included additional features and adequate consideration was not given to the need for a new Regulatory filing. |
| Root cause | No Marketing Application |
| Action | On 10/19/2022, the firm initially emailed its customer to inform them that Disc Preparation Instruments were developed, manufactured, and distributed that included an additional feature and the product did not go through the appropriate regulatory Pre-Market filing. Customer are instructed to: 1) Promptly review their inventory to determine if any of the affected product listed above is within their possession. 2) Abstain from sale and/or use and contact Alphatec Spine Customer Service for instructions on how to carry out a product return. All shipping instructions will be provided, including |
| Quantity | 42 devices |
| Distribution | U.S.: CA O.U.S.: N/A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.