Femoral Nail T2 GTN Left and Right Versions Mislabeled
Stryker GmbH is recalling certain Femoral Nail T2 GTN devices because some labeled as left version contained right nails, and vice versa. This mislabeling could result in incorrect surgical implantation.
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: This is an FDA Class II recall involving a high-risk surgical implant where mislabeling could directly cause patient harm through incorrect surgical placement. The source text does not report any actual illnesses or injuries, but the defect presents a documented risk of harm to patients who receive the incorrectly labeled device.
Plain-English summary
Stryker GmbH is recalling specific lots of the Femoral Nail, LEFT T2 GTN 8x300 mm (Catalog Number: 1850-0830S). Investigation determined that one lot labeled as left version actually contained a right nail, while another lot labeled as right version actually contained a left nail.
The mislabeling could lead to incorrect implantation during surgical procedures, potentially compromising patient outcomes. The affected products were distributed worldwide, including nationwide distribution in California and Missouri, as well as Belgium, Japan, and the Netherlands.
Patients who have received this device or healthcare providers with inventory of the affected lot (Batch lot number: K09F126, GTIN: 04546540646293) should contact Stryker GmbH immediately. Surgical teams should verify the actual orientation of any implanted or stored Femoral Nail T2 GTN devices from the affected lot before use.
The recalled product
- Product
- Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.
- Manufacturer
- Stryker GmbH
- Hazard
- mis-labeling
- surgical-device-mislabeling
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: 1850-0830S. GTIN: 04546540646293. Batch lot number: K09F126
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22