Greater Trochanter Nail Left-Right Labeling Error Prompts Stryker Recall
Stryker recalled the T2 Greater Trochanter Nail femoral implant due to labeling errors where affected lots contained opposite-sided nails. The product was distributed in the US, Belgium, Japan, and the Netherlands.
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 of a surgical implant with a confirmed labeling error where opposite-sided products were distributed, creating a risk of incorrect surgical procedures. No injuries have been reported to date, placing it in the risk-of-harm category without reported injury.
Plain-English summary
Stryker GmbH is recalling the T2 Greater Trochanter Nail (GTN), Catalog Number 1851-0830S, following an investigation that identified labeling errors in distributed lots. One lot labeled as the left-sided version was found to contain right-sided implants, and another lot labeled as the right-sided version was found to contain left-sided implants.
The affected lot number is K09F17F. Recipients of this product should verify that the contents match the package labeling to identify any discrepancies.
The product was distributed worldwide, including in California and Missouri in the United States, as well as in Belgium, Japan, and the Netherlands.
The recalled product
- Product
- Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.
- Manufacturer
- Stryker GmbH
- Hazard
- labeling-error
- wrong-surgical-side
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.
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