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.
Check against the official notice below — it lists the full affected range.
Implant Direct Sybron Manufacturing, LLC is recalling 158 units of ImplantDirect simply RePlant Implant (size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U) because an incorrect device was packaged in the vial. The affected lot is 108191 with an expiration date of January 18, 2023. This product was distributed to dental practices and medical facilities in 16 U.S. states (Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Kentucky, Massachusetts, Maryland, New Mexico, Nevada, New York, Pennsylvania, and Texas) and five countries outside the United States (Germany, Great Britain, Italy, Spain, Trinidad & Tobago, and the United Arab Emirates).
The source document does not specify a remedy or instructions for what consumers should do regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
The incorrect device was packaged in the vial.
Reason for recall: The incorrect device was packaged in the vial. 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. Quantity: 158 devices Lot/code info: Lot 108191, UDI (01)10841307108313(17)230118(10)108191
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.