medical Class II Updated 2019-10-09

Implant Direct Sybron Manufacturing, LLC recalls ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4

Recalled Product

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.


Hazard / Issue

The incorrect device was packaged in the vial.

Issued by

FDA

Affected States: AL, AZ, CA, CO, CT, FL, GA, ID, IL, KY, MA, MD, NM, NV, NY, PA, TX
Lot/Code Info: Lot 108191, UDI (01)10841307108313(17)230118(10)108191
View official government recall

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