FDA Medical devices recall ·
Femoral Nail, LEFT T2 GTN 8x300 mm recall
- Recall number
- Z-1939-2025
- Date
- (initiated May 22, 2025)
- Company / brand
- Stryker GmbH
Bohnackerweg 1, Selzach, Switzerland - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.
Why was it recalled?
Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Catalog Number: 1850-0830S. GTIN: 04546540646293. Batch lot number: K09F126
Distribution
Worldwide - US Nationwide distribution in the states of California and Missouri. The countries of Belgium, Japan, Netherlands.
States: California Missouri
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1939-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.