Halyard Total Knee Surgical Kit Recalled for Loose Metal Flakes
AVID Medical is recalling Halyard total knee surgical kits due to loose metal flakes on sponge forceps and towel clamps that could enter and contaminate the surgical site. The defect poses a risk of local reactions or foreign body complications.
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 FDA Class II recall involves a risk-of-harm hazard in a surgical context where metal fragments could cause local or foreign body reactions. However, no injuries, illnesses, or hospitalizations have been reported. The defect is theoretical rather than a documented adverse event, placing it at the High severity level per the rubric.
Plain-English summary
AVID Medical, Inc. is recalling the Halyard KIT, TOTAL KNEE (Model Number ESJH012-07) because the sponge forceps and towel clamps included in the kit contain small loose metal flakes that could potentially detach during use.
These loose metal flakes could undetectably enter a patient's surgical site during a procedure and cause local reactions or foreign body reactions. The metal fragments pose a risk of harm if not removed from the surgical field.
The recall affects 117 units distributed nationwide across the United States. Lot Number 1606092 is affected. Healthcare facilities and surgical centers currently using these kits should discontinue use immediately and contact AVID Medical, Inc. for recall instructions and options for replacement or return.
The recalled product
- Product
- Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: ESJH012-07
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 117
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: 10809160421857 Lot Number: 1606092
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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