The Recall Desk
SevereFDA (Devices)·Z-2406-2018·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 in a load-bearing medical device that could lead to premature breakage, meeting the criteria for a Severe rating.

Plain-English summary

Stryker GmbH is recalling specific units of the Femoral Nail, RIGHT T2 GTN 14x460 mm, Product Number 18511446S. 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 for the recalled items is K0748D3, and the GTIN is 07613252129295.

Healthcare providers and facilities that have received these products should stop using them and contact Stryker GmbH for further instructions on the recall process.

The recalled product

Product
Femoral Nail, RIGHT T2 GTN ¿14x460 mm, Product Number 18511446S
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: 07613252129295
  • Lot code: K0748D3

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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