RePlant¿ Angled Abutment Part Number 6050-52-60
Reported: August 10, 2016 Initiated: July 5, 2016 #Z-2320-2016
Product Description
RePlant¿ Angled Abutment Part Number 6050-52-60
Reason for Recall
Issue with design specification; oversized condition.
Details
- Recalling Firm
- Implant Direct Sybron Manufacturing, LLC
- Units Affected
- 205
- Distribution
- 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.
- Location
- Westlake Village, CA
Frequently Asked Questions
What product was recalled? ▼
RePlant¿ Angled Abutment Part Number 6050-52-60. Recalled by Implant Direct Sybron Manufacturing, LLC. Units affected: 205.
Why was this product recalled? ▼
Issue with design specification; oversized condition.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 10, 2016. Severity: Moderate. Recall number: Z-2320-2016.
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