The Recall Desk
SevereFDA (Devices)·Z-2408-2018·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 (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
Category
Medical Device — Orthopedic Implants
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: 04546540673428
  • Lot code: K081639

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

Same manufacturer · Stryker GmbH

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Same hazard · structural failure

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