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Recall Observatory FDA recall evidence

Device product

RePlant¿ Angled Abutment Part Number 6050-52-60

Z-2320-2016

July 05, 2016

Class II

Product summary

Firm
Implant Direct Sybron Manufacturing, LLC
Event
Event 74624
Status
Terminated
Classification
Class II
Quantity
205
Official record key
device-enforcement:Z-2320-2016

Official wording

Reason: Issue with design specification; oversized condition.

Code information: Lot #50174, 39799, 49364

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Issue with design specification; oversized condition.