Stryker Recalls Ankle Arthrodesis Nails Due to Potential Breakage Risk
Stryker GmbH is recalling specific ankle arthrodesis nails because non-conforming cannulation may reduce strength and cause premature breakage.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a medical implant that could lead to premature breakage, which aligns with the rubric criteria for Severe severity (structural defect/significant injury risk).
Plain-English summary
Stryker GmbH is recalling specific units of the Ankle Arthrodesis Nail, right T2 Ankle 10x300mm, Product Number 18191030S. The recall was initiated after the manufacturer discovered that potentially out-of-specification products may have left the factory.
The identified issue involves non-conforming cannulation of the nails, which may result in reduced component strength and potentially premature nail breakage. The affected products were distributed to the following US states: AL, CO, FL, KY, NC, TN, UT, and WA. The specific lot code is K078C7E and the GTIN is 04546540673398.
Healthcare providers and patients should check their inventory and medical records for this specific product number and lot code. If the product is found, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed.
The recalled product
- Product
- Ankle Arthrodesis Nail, right T2 Ankle ¿10x300mm, Product Number 18191030S
- Manufacturer
- Stryker GmbH
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 (2)
- GTIN: 04546540673398
- Lot code: K078C7E
Distribution
Part of a larger recall action
This product is one of 16 recalled by Stryker GmbH 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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