The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2401-2018·Announced 2018-07-18

Stryker Recalls Specific Femoral Nail Products Due to Potential Breakage

Stryker GmbH is recalling specific femoral nails due to potential manufacturing defects that could cause the device to break prematurely.

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 result in significant injury if the device breaks.

Plain-English summary

Stryker GmbH is recalling specific units of the Femoral Nail, A/R, R1500 T2 Femur 12x380 mm (Product Number 18281238S). The recall is limited to units with Lot code K08327F and GTIN 04546540200693.

The manufacturer identified that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength, which could potentially lead to premature nail breakage.

The affected 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 the specific lot and product numbers listed and stop using the affected devices.

The recalled product

Product
Femoral Nail, A/R, R1500 T2 Femur ¿12x380 mm, Product Number 18281238S
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: 04546540200693
  • Lot code: K08327F

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

Same manufacturer · Stryker GmbH

See all →

Same hazard · structural failure

See all →

Similar recalls