The Recall Desk
SevereFDA (Devices)·Z-2407-2018·Announced 2018-07-18

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
Category
Medical Device — Orthopedic Implant
Hazard

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

Distributed in 8 states:

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.

See all 16 products in this recall →

Related recalls

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Same hazard · structural failure

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