The Recall Desk
SevereFDA (Devices)·Z-2404-2018·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 involves a structural defect in a medical implant (premature breakage) which poses a significant risk of injury, meeting the criteria for a Severe rating.

Plain-English summary

Stryker GmbH is recalling the Femoral Nail, LEFT T2 GTN 14x300 mm, Product Number 18501430S. The manufacturer identified that potentially out-of-specification products may have left the factory.

The recall is due to non-conforming cannulation of the nails, which may result in reduced component strength and potentially premature nail breakage. The products were distributed to the following US states: AL, CO, FL, KY, NC, TN, UT, and WA.

The affected products have GTIN 04546540647078 and Lot code K078C74. Healthcare providers and patients should contact Stryker GmbH for further instructions regarding the recall.

The recalled product

Product
Femoral Nail, LEFT T2 GTN ¿14x300 mm, Product Number 18501430S
Manufacturer
Stryker GmbH

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: 04546540647078
  • Lot code: K078C74

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 →