Implant Direct Sybron Manufacturing, LLC recalls REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
- Recall date
- May 18, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2376-2018
- FDA classification
- Class II
- Brand / firm
- Implant Direct Sybron Manufacturing, LLC
- Sold / distributed
- CA, FL, GA, IL, LA, MI, MT, NC, NJ, NY, OK, OR, SC, SD, TN & WA; International: Jordan, Great Britain, Germany, Spain, Italy & Poland
Why it was recalled
Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant
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 5.0mmD ABUTMENT, Part number 6050-52-60
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