Zimmer Dental Recalls Tapered Screw-Vent Implant Lot Due to Labeling Error
Zimmer Dental is voluntarily recalling a specific lot of Tapered Screw-Vent Implants because some packages may display incorrect size information on the cap label.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: The recall is classified as Moderate because it involves a minor labeling error on a Class II medical device, which fits the rubric criteria for minor labeling errors and voluntary precautionary recalls.
Plain-English summary
Zimmer Dental Inc is conducting a voluntary recall of a single lot of Tapered Screw-Vent Implants (Catalog Number TSVWB11, Lot 62470008). The recall is being issued because some packages from this lot may have a cap label that incorrectly states the dimensions as "3.7 x 10mm" instead of the correct "4.7 x 11.5mm".
The affected product is a Class II medical device, 510(k) K13227, manufactured by Zimmer Dental Inc. A total of 307 units were distributed worldwide, including nationwide in the United States and in Thailand, Japan, Hong Kong, Morocco, and the UAE.
Consumers and healthcare providers should check the catalog number and lot number on their implants to see if they are affected. If the product matches the recalled lot, users should contact Zimmer Dental for further instructions on how to proceed.
The recalled product
- Product
- Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.
- Manufacturer
- Zimmer Dental Inc
- Category
- Medical Device — Dental Implant
- Hazard
- Affected units
- 307
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 TSVWB11
- Lot 62470008.
Distribution
Distributed nationwide across the United States.
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Similar recalls
- ModerateZimmer Dental Recalls Tapered Screw-Vent Implants Due to Labeling Error
FDA (Devices) · 2014-11-05
- LowZimmer Dental Implants Recalled for Incorrect Inner Package Labeling
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