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Recall Observatory FDA recall evidence

Device product

Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.

Z-0847-2014

January 06, 2014

Class II

Product summary

Firm
Zimmer Dental Inc
Event
Event 67207
Status
Terminated
Classification
Class II
Quantity
307
Official record key
device-enforcement:Z-0847-2014

Official wording

Reason: Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog TSVWB11, Lot 62470008, because some of the packages of this lot may have the Cap Label state ¿3.7 x 10mm instead of ¿4.7 x 11.5mm.

Code information: Catalog Number TSVWB11, Lot 62470008.

Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Thailand, Japan, Hong Kong, Morocco, and UAE.

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 TSVWB11, Lot 62470008, because some of the packages of this lot may have the Cap Label state ¿3.7 x 10mm instead of ¿4.7 x 11.5mm.