FDA Medical devices recall ·
PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW recall
- Recall number
- Z-2025-2025
- Date
- (initiated May 19, 2025)
- Company / brand
- Limacorporate S.p.A
Via Nazionale 52, San Daniele Del Friuli, Italy - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 9 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile
Why was it recalled?
There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
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
Lot number 2421400/UDI: 08033390201834
Distribution
Worldwide - US Nationwide distribution in the states of VA, FL, SC, MS, NY, TX and the countries of Italy, Poland, France.
States: Florida Mississippi New York South Carolina Texas Virginia
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-2025-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.