Recall Z-1497-2024— Synovo Production
Class II · Ongoing
Class II FDA medical device recall by Synovo Production, initiated 2023-05-30. FDA's recall record names no specific 510(k) clearance for this event. Product: ACETABULAR BEARING (xx)MM I.D X (xx) O.D. UHMWPE 1020, STERILEEO, Reference Numbers: 01-02-4254 01-02-4456 01-02-4558 01-02-4760 01-02-4962 01-02-5164 01-02-5266. Reason: Medical device components were marketed without FDA clearance.
- Recalling firm
- Synovo Production
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-05-30
- Firm location
- Fullerton, CA, United States
Product description
ACETABULAR BEARING (xx)MM I.D X (xx) O.D. UHMWPE 1020, STERILEEO, Reference Numbers: 01-02-4254 01-02-4456 01-02-4558 01-02-4760 01-02-4962 01-02-5164 01-02-5266
Reason for recall
Medical device components were marketed without FDA clearance
Data sourced from openFDA. This site is unofficial and independent of the FDA.