Surgical room, Implant Pack, Item No.41111UTI, oral surgery tray
Reported: December 21, 2022 Initiated: November 2, 2022 #Z-0494-2023
Product Description
Surgical room, Implant Pack, Item No.41111UTI, oral surgery tray
Reason for Recall
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Details
- Recalling Firm
- Stradis Medical, LLC dba Stradis Healthcare
- Units Affected
- 162 units
- Distribution
- US nationwide distribution, and Canada.
- Location
- Peachtree Corners, GA
Frequently Asked Questions
What product was recalled? ▼
Surgical room, Implant Pack, Item No.41111UTI, oral surgery tray. Recalled by Stradis Medical, LLC dba Stradis Healthcare. Units affected: 162 units.
Why was this product recalled? ▼
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 21, 2022. Severity: Moderate. Recall number: Z-0494-2023.
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