Disc Preparation instruments contained in the following products: CI-11050-08102515 Longer IdentiTi PO Trial Tip, 11A X

FDA device recall Z-0196-2023 · posted 2022-11-08 · Open, Classified

Recall details

Recalling firm

Alphatec Spine, Inc.

Reason for recall

Due to manufacturing instruments which included additional features and adequate consideration was not given to the need for a new Regulatory filing.

Action taken

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 arrangements for product replacement. 3) Fill out the last page of this letter to confirm that they have read this notification and have taken all necessary actions as described in this notification. 4) Return page 4 (signed) of this letter using one of the methods below: -Mail to: Alphatec Spine, Inc., 1950 Camino Vida Roble, Carlsbad, CA 92008 ATTN: Mihir Naik -Email to: QMSCompliance@atecspine.com For questions, contact 1-800-922-1356

Root cause

No Marketing Application

Status

Open, Classified

Product code

OLO

Quantity affected

42 devices

Distribution

U.S.: CA O.U.S.: N/A

Date initiated

2022-09-14

Date posted

2022-11-08

Location

Carlsbad, CA