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restor3d Inc. recalls Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials.
Recalled May 11, 2022 · FDA recall Z-1026-2022 · restor3d
Hazard
Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium. · FDA Class II
Units
14 units
Sold at
US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.
Description
Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.
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
Manufacturer(s)
restor3d Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →