The Recall Desk
SevereFDA (Devices)·Z-2399-2018·Announced 2018-07-18

Stryker Recalls Femoral Nails Due to Potential Premature Breakage

Stryker GmbH is recalling specific femoral 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 breakage) in a load-bearing orthopedic implant, which poses a significant risk of injury.

Plain-English summary

Stryker GmbH is recalling specific femoral nails (Product Number 18281230S) because the manufacturer discovered that potentially out-of-specification products may have left the factory. The recall involves a specific lot (K07AFF5) and GTIN (04546540200655).

The recall is due to non-conforming cannulation of the nails, which may result in reduced component strength and potentially premature nail breakage. This is classified as an FDA Class II recall.

The 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 on how to proceed.

The recalled product

Product
Femoral Nail, A/R, R1500 T2 Femur ¿12x300 mm, Product Number 18281230S
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: 04546540200655
  • Lot code: K07AFF5

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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