Implant Direct Sybron Manufacturing, LLC recalls RePlant¿ Angled Abutment Part Number 6050-52-60
- Recall date
- July 5, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2320-2016
- FDA classification
- Class II
- Brand / firm
- Implant Direct Sybron Manufacturing, LLC
- Sold / distributed
- 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.
Why it was recalled
Issue with design specification; oversized condition.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
RePlant¿ Angled Abutment Part Number 6050-52-60
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