Recall Z-1026-2022— restor3d Inc.

Name: FDA recall Z-1026-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-30

Class II · Terminated

Class II FDA medical device recall by restor3d Inc., initiated 2022-03-30, terminated 2023-08-28. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium..

Recalling firm: restor3d Inc.
Classification: Class II
Status: Terminated
Initiated: 2022-03-30
Terminated: 2023-08-28
Firm location: Durham, NC, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.