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Recall Observatory FDA recall evidence

Device product

Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006

Z-2050-2014

June 25, 2014

Class II

Product summary

Firm
Zimmer, Inc.
Event
Event 68584
Status
Terminated
Classification
Class II
Quantity
129 units
Official record key
device-enforcement:Z-2050-2014

Official wording

Reason: Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog Number TSVT6B13, Lot number 62284006, due to a potential crack in the cap of the outer vial.

Code information: Catalog Number TSVT6B13, Lot Number 62284006. 5-year expiration. January 2018.

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog Number TSVT6B13, Lot number 62284006, due to a potential crack in the cap of the outer vial.