FDA recall Z-0650-2025

Product

DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Large Obturator Trocar (Model Number 330.017) 2. DKS Large Lighted Cannula (Model Number 330.011) 3. DKS Large Kerrison (330.015) 4. DKS Small Obturator Trocar (330.013) 5. DKs Small Lighted Cannula (330.014) 6. DKS Small Kerrison (330.016)

Reason for recall

Units were not intended for commercial distribution and inadvertently distributed.

Distribution

US distribution to KS, LA, MI, NY, TX.

Key facts

Status

Ongoing

Initiation date

2023-10-30

Report date

2024-12-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pelham, AL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0650-2025