Z-1026-2022 Class II Terminated

Recalled by restor3d Inc. — Durham, NC

Recall Details

Product Type
Devices
Report Date
May 11, 2022
Initiation Date
March 30, 2022
Termination Date
August 28, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14 units

Product Description

Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical instrument

Reason for Recall

Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.

Distribution Pattern

US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.

Code Information

Model: 6110-N01-KTS01 Lot: 2022030005 UDI: 00840097504506