Halyard Total Knee Medical Kits Recalled for Potential Metal Flakes in Surgical Instruments
AVID Medical is recalling Halyard KIT, TOTAL KNEE medical convenience kits due to loose metal flakes in sponge forceps and towel clamps that could contaminate surgical sites.
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: This is a Class II medical device recall involving surgical instruments with potential risk of patient harm through foreign body contamination in a surgical field. No illnesses or injuries have been reported to date, making this a risk-of-harm product without documented adverse events, which meets the rubric criterion for High severity.
Plain-English summary
AVID Medical, Inc. is recalling Halyard KIT, TOTAL KNEE medical convenience kits, Model Number EUOR002-06 (Lot 1611448), distributed nationwide in the United States. The sponge forceps and towel clamps included in these kits may contain small loose metal flakes that could detach during surgical use.
If metal flakes detach and enter a patient's surgical site undetected, they could cause local reactions or foreign body reactions. This risk applies to patients undergoing total knee procedures using these kits.
Consumers and healthcare facilities with this product should discontinue use immediately and contact AVID Medical, Inc. for instructions. Patients who have already undergone surgery using instruments from an affected kit and experience any complications should seek medical attention promptly.
The recalled product
- Product
- Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-06
- Manufacturer
- AVID Medical, Inc.
- Hazard
- Affected units
- 129
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 (1)
- GTIN: 10809160426210 Lot Number: 1611448
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 73 recalled by AVID Medical, 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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