Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Reported: October 11, 2017 Initiated: July 21, 2017 #Z-0007-2018
Product Description
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Reason for Recall
The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component.
Details
- Recalling Firm
- Implant Direct Sybron Manufacturing, LLC
- Units Affected
- 50 units
- Distribution
- Distribution US nationwide including CA, FL, NJ, NY, PA, TX, & UT.
- Location
- Westlake Village, CA
Frequently Asked Questions
What product was recalled? ▼
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.. Recalled by Implant Direct Sybron Manufacturing, LLC. Units affected: 50 units.
Why was this product recalled? ▼
The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 11, 2017. Severity: Moderate. Recall number: Z-0007-2018.
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