FDA Medical devices recall ·
Offset Cup Impactor - 3/8-16 interface recall
- Recall number
- Z-0549-2025
- Date
- (initiated October 30, 2024)
- Company / brand
- Incipio Devices
avenue des Paquiers 16, St-Blaise, Switzerland - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 100 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
Why was it recalled?
Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
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
Product Reference No.: 50341105; UDI-DI: 07630055304735; Lot No.: 24A0087.
Distribution
US Nationwide distribution in the state of TN.
States: Tennessee
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-0549-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.