FDA recall Z-1026-2022

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 for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2022-03-30

Report date

2022-05-11

Termination date

2023-08-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Durham, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1026-2022