Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY, STERILEEO, Reference Numbers: 01-03-0042 01-03-0044 01-03-0045 01-03-0047 01-03-0049 01-03-0051 01-03-0052
Reported: April 17, 2024 Initiated: May 30, 2023 #Z-1498-2024
Product Description
Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY, STERILEEO, Reference Numbers: 01-03-0042 01-03-0044 01-03-0045 01-03-0047 01-03-0049 01-03-0051 01-03-0052
Reason for Recall
Medical device components were marketed without FDA clearance
Details
- Recalling Firm
- Synovo Production
- Units Affected
- 496 units
- Distribution
- US Nationwide distribution in the state of WA.
- Location
- Fullerton, CA
Frequently Asked Questions
What product was recalled? ▼
Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY, STERILEEO, Reference Numbers: 01-03-0042 01-03-0044 01-03-0045 01-03-0047 01-03-0049 01-03-0051 01-03-0052. Recalled by Synovo Production. Units affected: 496 units.
Why was this product recalled? ▼
Medical device components were marketed without FDA clearance
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 17, 2024. Severity: Moderate. Recall number: Z-1498-2024.
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