The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2398-2018·Announced 2018-07-18

Stryker Recalls Seven Femoral Nails Due to Potential Breakage Risk

Stryker GmbH is recalling seven femoral nails because non-conforming cannulation may reduce strength and cause 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. Per the rubric, FDA Class II recalls involving significant injury risks or structural defects in medical devices are categorized as Severe (Score 4).

Plain-English summary

Stryker GmbH is recalling seven units of the Femoral Nail, A/R, R1500 T2 Femur 10x320 mm (Product Number 18281032S). The recall was initiated after 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 are identified by GTIN 04546540200402 and Lot code K08327D.

The products were distributed to the following US states: AL, CO, FL, KY, NC, TN, UT, and WA. Healthcare providers and facilities should check their inventory for this specific lot and product number and contact Stryker for further instructions.

The recalled product

Product
Femoral Nail, A/R, R1500 T2 Femur ¿10x320 mm, Product Number 18281032S
Manufacturer
Stryker GmbH
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
7

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 04546540200402
  • Lot code: K08327D

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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