Recall Z-0650-2025— Folsom Metal Products, Inc.
Class II · Ongoing
Class II FDA medical device recall by Folsom Metal Products, Inc., initiated 2023-10-30. FDA's recall record names no specific 510(k) clearance for this event. 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: Units were not intended for commercial distribution and inadvertently distributed..
- Recalling firm
- Folsom Metal Products, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-10-30
- Firm location
- Pelham, AL, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.