The Recall Desk
HighFDA (Devices)·Z-2402-2018·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 cause premature breakage.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device where a structural defect could lead to injury, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Stryker GmbH is recalling specific units of the Femoral Nail, LEFT T2 GTN 10x360 mm, Product Number 18501036S. 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 K08D58D, and the GTIN is 04546540646583.

Healthcare providers and patients should contact Stryker GmbH for further instructions regarding the return or replacement of these devices. The source text does not report any specific injuries or illnesses associated with this recall.

The recalled product

Product
Femoral Nail, LEFT T2 GTN ¿10x360 mm, Product Number 18501036S
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: 04546540646583
  • Lot code: K08D58D

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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