ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Reported: October 9, 2019 Initiated: August 7, 2018 #Z-0010-2020
Product Description
ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Reason for Recall
The incorrect device was packaged in the vial.
Details
- Recalling Firm
- Implant Direct Sybron Manufacturing, LLC
- Units Affected
- 158 devices
- Distribution
- Distribution was made to AL, AZ, CA, CO, CT, FL, GA, ID, IL KY, MA, MD, NM, NV, NY, PA, and TX. There was no government/military distribution. Foreign distribution was made to Germany, Great Britain, Italy, Spain, Trinidad & Tobago, and UAE.
- Location
- Westlake Village, CA
Frequently Asked Questions
What product was recalled? ▼
ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.. Recalled by Implant Direct Sybron Manufacturing, LLC. Units affected: 158 devices.
Why was this product recalled? ▼
The incorrect device was packaged in the vial.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 9, 2019. Severity: Moderate. Recall number: Z-0010-2020.
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