The Recall Desk
HighFDA (Devices)·Z-0282-2018·Announced 2017-12-27

Zimmer Dental Tapered Screw-Vent Implant Surgical Kits Recalled for Geometry Defect

Zimmer Dental Inc. is recalling 891 Tapered Screw-Vent Implant System surgical kits because a manufacturing defect in the driver's hex feature may prevent proper engagement with dental implants.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device) where the defect may prevent proper engagement of implants, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.

Plain-English summary

Zimmer Dental Inc. is recalling 891 units of the Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, Complete, Ref TSVKIT. The recall is due to a manufacturing condition affecting the geometry of the driver's hex feature. This defect may prevent the driver from properly engaging the fixture mount transfer and/or a dental implant.

The affected kits were distributed worldwide, including in the United States (nationwide), Canada, Australia, and numerous other countries. The specific lot numbers involved are 63581758, 63583277, 63587717, 63623845, 63632463, 63632464, 63666560, 63669280, 63676567, 63676568, 63693941, 63694051, 63715410, 63716081, 63724569, 63724570, 63728840, 63735508, 63735987, 63739443, 63743229, 63748227, and 63750186.

These devices are manually powered instruments intended to aid in the placement or removal of endosseous dental implants and abutments. The source text does not report any illnesses or injuries associated with this recall. Healthcare providers and consumers should check their inventory for the listed lot numbers and contact Zimmer Dental Inc. for further instructions.

The recalled product

Product
Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, Complete, Ref TSVKIT. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in th
Manufacturer
Zimmer Dental Inc
Category
Medical Device — Dental Implant Instruments
Hazard
Affected units
891

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot numbers 63581758
  • 63583277
  • 63587717
  • 63623845
  • 63632463
  • 63632464
  • 63666560
  • 63669280
  • 63676567
  • 63676568
  • 63693941
  • 63694051
  • 63715410
  • 63716081
  • 63724569
  • 63724570
  • 63728840
  • 63735508
  • 63735987
  • 63739443

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Zimmer Dental Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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