ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Reported: August 1, 2018 Initiated: March 3, 2017 #Z-2551-2018
Product Description
ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Reason for Recall
The main vial label lists the incorrect part number, but the cap label is correct.
Details
- Recalling Firm
- Implant Direct Sybron Manufacturing, LLC
- Units Affected
- 124 units
- Distribution
- Distribution was made to AZ, CA, CO, CT, FL, ID, IL, NC, NJ, NV, NY, PA, TX, UT, VA, and WA. There was no government/military distribution. Foreign distribution was made to Switzerland, Germany, Lithuania, and Spain.
- Location
- Thousand Oaks, CA
Frequently Asked Questions
What product was recalled? ▼
ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.. Recalled by Implant Direct Sybron Manufacturing, LLC. Units affected: 124 units.
Why was this product recalled? ▼
The main vial label lists the incorrect part number, but the cap label is correct.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 1, 2018. Severity: Moderate. Recall number: Z-2551-2018.
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