Stryker Tibial Nail Recall Due to Potential Premature Breakage
Stryker GmbH is recalling specific Tibial 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 breakage) in an orthopedic implant, which poses a significant risk of injury.
Plain-English summary
Stryker GmbH is recalling 12 units of Tibial Nail, Standard T2 Tibia 12x315 mm (Product Number 18221231S). The recall involves units with GTIN 04546540197771 and Lot code K074846.
The manufacturer identified that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength, which could potentially lead to premature nail breakage.
The affected products were distributed to the following US states: AL, CO, FL, KY, NC, TN, UT, and WA. Healthcare providers and patients should contact Stryker GmbH for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Tibial Nail, Standard T2 Tibia ¿12x315 mm, Product Number 18221231S
- Manufacturer
- Stryker GmbH
- Affected units
- 12
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 04546540197771
- Lot code: K074846
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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