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 (premature nail breakage) in an orthopedic implant, which poses a risk of significant injury.
Plain-English summary
Stryker GmbH is recalling specific Ankle Arthrodesis Nails (right T2 Ankle 11x300mm, Product Number 18191130S) due to potential manufacturing defects. The manufacturer discovered that potentially out-of-specification products may have left the factory.
The recall is issued because non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. This is classified as an FDA Class II recall.
The affected products were distributed to the following US states: AL, CO, FL, KY, NC, TN, UT, and WA. The specific lot code is K081639 and the GTIN is 04546540673428. Healthcare providers and patients should check their inventory or medical records for this specific product number and lot code. If the product is in use, patients should contact their healthcare provider for evaluation and potential replacement.
The recalled product
- Product
- Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm, Product Number 18191130S
- 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: 04546540673428
- Lot code: K081639
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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