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.
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 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
- Affected units
- 1
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
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 →Related recalls
Same manufacturer · Stryker GmbH
See all →- HighStryker Hoffmann II Carbon Connecting Rods Recalled Over Potential Cracking After Sterilization
FDA (Devices) · 2026-08-05
- HighStryker Hoffmann II Connecting Rod Micro May Crack After Cleaning and Sterilization
FDA (Devices) · 2026-08-05
- HighStryker Hoffmann II Carbon Connecting Rods Recalled Over Potential Cracking After Sterilization
FDA (Devices) · 2026-08-05
- HighStryker Hoffmann II Carbon Connecting Rods Recalled Over Potential Cracking After Sterilization
FDA (Devices) · 2026-08-05
- HighStryker Hoffmann II Carbon Connecting Rods Recalled Over Potential Cracking
FDA (Devices) · 2026-08-05
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- LowMagellan LeadCare II Blood Lead Test Kit Recall for Labeling Error
FDA (Devices) · 2026-10-21
- ModerateIn2bones Recalls Partially Threaded Bone Screws Due to Labeling Error
FDA (Devices) · 2026-10-21
- SevereInstrumentation Laboratory Recalls HemoslL AcuStar HIT-lgG In Vitro Diagnostic Reagents
FDA (Devices) · 2026-10-21
- SevereDeano's Pasta Recalls Pear and Pecorino Ravioli for Undeclared Lobster
FDA (Food) · 2026-10-21
Similar recalls
- ModerateStryker Recalls Mislabelled Femoral and Tibial Nails
FDA (Devices) · 2016-09-21
- HighStryker Recalls Femoral Nails Due to Potential Premature Breakage
FDA (Devices) · 2018-07-18
- ModerateStryker Recalls Mislabelled T2 Supracondylar Nail System
FDA (Devices) · 2016-09-21
- SevereStryker Recalls Two Femoral Nails Due to Potential Premature Breakage
FDA (Devices) · 2018-07-18
- SevereStryker Recalls Specific Femoral Nail Due to Potential Breakage Risk
FDA (Devices) · 2018-07-18
- SevereStryker Recalls Specific Femoral Nail Products Due to Potential Breakage
FDA (Devices) · 2018-07-18