The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2394-2018·Announced 2018-07-18

Stryker Recalls Two Femoral Nails Due to Potential Premature Breakage

Stryker GmbH is recalling two femoral nails that may have non-conforming cannulation, potentially leading to reduced strength and premature breakage.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 two units of the Femoral Nail, A/R T2 Femur 10x320 mm (Product Number 18251032S). The recall was initiated 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, 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 K081642.

Healthcare providers and patients should check their inventory and records for this specific product number and lot code. If the product is found, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed.

The recalled product

Product
Femoral Nail, A/R T2 Femur ¿10x320 mm, Product Number 18251032S
Manufacturer
Stryker GmbH
Category
Medical Device — Orthopedic Implants
Hazard
Affected units
2

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 04546540199492
  • Lot code: K081642

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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