restor3d Inc.: Medical Device Recall in 2022 - (Recall #: Z-1026-2022)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2022.
Data Source: FDA.
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
Product Classification:
Class II
Date Initiated: March 30, 2022
Date Posted: May 11, 2022
Recall Number: Z-1026-2022
Event ID: 89983
Reason for Recall:
Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.
Status: Terminated
Product Quantity: 14 units
Code Information:
Model: 6110-N01-KTS01 Lot: 2022030005 UDI: 00840097504506
Distribution Pattern:
US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.
Voluntary or Mandated:
Voluntary: Firm initiated