The Recall Desk
SevereFDA (Devices)·Z-2405-2018·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 component strength and lead to 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 agency classification is Class II. The hazard involves a structural defect in a load-bearing medical device (femoral nail) that could lead to premature breakage, which aligns with the rubric criterion for 'structural vehicle defect' or 'significant injury/property-damage reports' by analogy to structural integrity failures in critical medical implants.

Plain-English summary

Stryker GmbH is recalling specific units of the Femoral Nail, RIGHT T2 GTN 9x320 mm (Product Number 18510932S). The recall is being conducted because the manufacturer discovered that potentially out-of-specification products may have left the factory.

The specific defect involves non-conforming cannulation of the nails. This issue 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 K076A80 and the GTIN is 04546540647320.

Healthcare providers and patients should contact Stryker GmbH for further instructions on how to handle the recalled devices. The source text does not specify the number of affected units or report any illnesses or injuries.

The recalled product

Product
Femoral Nail, RIGHT T2 GTN ¿9x320 mm, Product Number 18510932S
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: 04546540647320
  • Lot code: K076A80

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 →

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