Halyard TOTAL KNEE Medical Convenience Kits Recalled for Loose Metal Flakes
AVID Medical is recalling Halyard TOTAL KNEE kits because sponge forceps and towel clamps may have loose metal flakes that could detach and enter a patient's surgical site, causing local or foreign body reactions.
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 an FDA Class II medical device recall involving potential for serious harm if metal flakes detach and enter a surgical site. However, no injuries or illnesses have been reported. The hazard is contingent on flake detachment and field entry, fitting the criterion of risk-of-harm products without reported injury.
Plain-English summary
AVID Medical, Inc. is recalling Halyard TOTAL KNEE medical convenience kits, Model Number GRND008-09, due to a potential safety concern with included surgical instruments.
The sponge forceps and towel clamps in these kits may have small loose metal flakes that could detach from the components. If metal flakes are not detected and enter a patient's surgical site during a procedure, they could cause local tissue reactions or foreign body reactions.
This recall affects Halyard TOTAL KNEE kits distributed nationwide in the United States. The affected lot number is 1596070.
Patients and healthcare providers should contact AVID Medical, Inc. for further instructions on handling the recalled product.
The recalled product
- Product
- Halyard TOTAL KNEE - Medical convenience kits Model Number: GRND008-09
- Manufacturer
- AVID Medical, Inc.
- Hazard
- Affected units
- 60
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: 10809160365779 Lot Number: 1596070
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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