Implant Direct Sybron Manufacturing, LLC recalls Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
- Recall date
- July 21, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0007-2018
- FDA classification
- Class II
- Brand / firm
- Implant Direct Sybron Manufacturing, LLC
- Sold / distributed
- Distribution US nationwide including CA, FL, NJ, NY, PA, TX, & UT.
Why it was recalled
The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
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