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Recall Observatory FDA recall evidence

Device product

Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Dental implant component.

Z-2144-2014

July 17, 2014

Class II

Product summary

Firm
Zimmer, Inc.
Event
Event 68862
Status
Terminated
Classification
Class II
Quantity
291 units
Official record key
device-enforcement:Z-2144-2014

Official wording

Reason: Zimmer Dental is recalling the Tapered Screw-Vent Implant because the inner vial state "03.7 x 8mm" instead of "04.7 x 8 mm."

Code information: Lot No. 62552804

Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Holland, Italy, and Japan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Zimmer Dental is recalling the Tapered Screw-Vent Implant because the inner vial state "03.7 x 8mm" instead of "04.7 x 8 mm."