The Recall Desk
ModerateFDA (Devices)·Z-2050-2014·Announced 2014-07-23

Zimmer Dental Tapered Screw-Vent Implant Recalled for Potential Vial Crack

Zimmer, Inc. is voluntarily recalling a specific lot of dental implants due to a potential crack in the outer vial cap.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a voluntary precautionary recall for a potential packaging defect (cracked vial cap) with no reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Zimmer, Inc. is conducting a voluntary recall of a single lot of the Zimmer Dental Tapered Screw-Vent Implant. The affected product is identified by Catalog Number TSVT613 and Lot Number 62284006. The recall involves 129 units that were distributed nationwide.

The reason for the recall is a potential crack in the cap of the outer vial. The source text does not report any illnesses, injuries, or adverse health consequences associated with this defect. The agency has classified this as a Class II recall.

Consumers and healthcare providers who have this specific lot of implants should stop using them and contact Zimmer, Inc. for further instructions. The source text does not provide specific contact details or a return address.

The recalled product

Product
Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006
Manufacturer
Zimmer, Inc.
Affected units
129

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 (2)

  • Catalog Number TSVT6B13
  • Lot Number 62284006. 5-year expiration. January 2018.

Distribution

Distributed nationwide across the United States.