FDA Recalls DKS Disposable Kerrison System Surgical Instruments
Folsom Metal Products recalls 42 sets of DKS Disposable Kerrison System surgical instruments inadvertently distributed without commercial distribution approval. Four units were not sterilized.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with documented sterilization failure (four units not sent to sterilization). Surgical instruments lacking sterilization represent a contamination and infection risk. No reported injuries or illnesses have been documented.
Plain-English summary
Folsom Metal Products, Inc. is recalling 42 sets of the DKS Disposable Kerrison System, catalog number DKS-63030. The product consists of surgical instrument sets in two sizes (3.75mm and 6.35mm), each containing obturator trocars, lighted cannulas, and Kerrison instruments in large and small variants.
The units were not intended for commercial distribution but were inadvertently distributed. Four specific units were not sent to sterilization and were not assigned lot numbers. The remaining units are associated with lot numbers 1560, 1567, and 1578.
The recalled products were distributed to healthcare facilities in Kansas, Louisiana, Michigan, New York, and Texas.
The recalled product
- 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…
- Manufacturer
- Folsom Metal Products, Inc.
- Hazard
- Affected units
- 42
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Catalog Number DKS-63030
- Lot Numbers: 1560
- 1567
- 1578. 4 units were not sent to sterilization
- therefore were not assigned lot numbers.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Folsom Metal Products, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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