Z-1026-2022 Class II Terminated
FDA device recall Z-1026-2022 was initiated by restor3d Inc. on March 30, 2022 and is designated Class II. Reason for recall: Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium. The recall status is terminated (terminated August 28, 2023). Affected quantity: 14 units.
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