Halyard Knee Arthroscopy Packs recalled due to loose metal flakes
AVID Medical recalls Halyard Knee Arthroscopy Packs due to loose metal flakes that could detach from forceps and clamps. Metal fragments may enter the surgical site, potentially causing local or foreign body reactions.
What this means for you
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 the potential for loose metal fragments to enter a surgical site. Although no illnesses or injuries have been reported and the hazard remains theoretical, the risk of foreign body reactions in orthopedic surgery justifies a High severity rating.
Plain-English summary
AVID Medical, Inc. is recalling Halyard Knee Arthroscopy Packs (Model MAMC204-16) distributed nationwide in the US. The kits contain sponge forceps and towel clamps that may have small loose metal flakes, which could potentially detach from these components during surgical use.
If metal flakes detach undetected, they may enter a patient's surgical site, potentially causing local reactions or foreign body reactions. The loose metal fragments pose a risk during knee arthroscopy procedures.
Affected surgical facilities should identify units with Lot Number 1608931 and contact their surgical supply chain to verify their stock. If any units from this lot are in inventory, facilities should consult with AVID Medical regarding proper handling or replacement.
Healthcare providers should be alert for any patient reports of complications potentially related to metal contamination during knee arthroscopy procedures.
The recalled product
- Product
- Halyard KNEE ARTHROSCOPY PACK - Medical convenience kits Model Number: MAMC204-16
- Manufacturer
- AVID Medical, Inc.
- Hazard
- foreign-body-risk
- metal-contamination
- loose-components
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: 10809160360767 Lot Number: 1608931
Distribution
Distributed nationwide across the United States.
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