The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1940-2025·Announced 2025-06-18

Femoral Nail RIGHT T2 GTN 8x300 mm labeled incorrectly

Stryker GmbH is recalling Femoral Nail RIGHT T2 GTN 8x300 mm devices because some lots were labeled as left or right but contained the opposite orientation.

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 3/5 (High).

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: This is an FDA Class II recall involving a medical device with risk of harm due to mislabeling that could result in implantation of an incorrectly oriented surgical nail. No illnesses or injuries are reported, but the potential for surgical complications from incorrect orientation meets the High severity threshold.

Plain-English summary

Stryker GmbH is recalling the Femoral Nail, RIGHT T2 GTN 8x300 mm (Catalog Number 1851-0830S, Batch Lot Number K09F17F) due to labeling errors. Investigation determined that one lot labeled as left version contained a right nail, and another lot labeled as right version contained a left nail.

The recalled devices were distributed worldwide, including US nationwide distribution in California and Missouri, as well as Belgium, Japan, and the Netherlands. Two units are affected by this recall.

Patients and healthcare providers who have received these devices should verify the orientation of the implant against the actual product received. Contact Stryker GmbH for guidance on whether the implant is appropriate for the intended surgical site or if replacement is necessary.

The recalled product

Product
Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.
Manufacturer
Stryker GmbH
Category
Medical Device — Orthopedic Surgical Implant
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 (1)

  • Catalog Number: 1851-0830S. GTIN: 04546540647184. Batch lot number: K09F17F

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

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