FDAFDA · Food and drugs·Recall number Z-2320-2016
RePlant¿ Angled Abutment Part Number 6050-52-60
Published August 10, 2016 · Recall initiated: July 5, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Issue with design specification; oversized condition.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Distributor
- U.S. distribution to the following; CA, WA, UT, GA, AZ, NE, OR, MI, TX, WI, FL, AL, AR, MO, VA, MA, TN, LA, NC, KS, NY, SC, OK. Foreign distribution to the following; CA, DE, IT, GB, PL, DE, GB, NL, GR, ES, HR, BG.
- Lot
- Lot #50174, 39799, 49364
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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