Zimmer Recalls Tapered Screw-Vent Dental Implant Due to Labeling Error
Zimmer, Inc. is recalling Tapered Screw-Vent Dental Implants because the inner vial is labeled with incorrect dimensions.
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 FDA Class II and involves a minor labeling error regarding product dimensions, which fits the criteria for a moderate severity score.
Plain-English summary
Zimmer, Inc. is voluntarily recalling 291 units of the Tapered Screw-Vent Implant, Part No. TSVWH8. This dental implant component was distributed nationwide in the United States and in Holland, Italy, and Japan.
The recall was initiated because the inner vial is labeled with the dimensions "03.7 x 8mm" instead of the correct "04.7 x 8 mm." This is a labeling discrepancy regarding the product specifications.
Consumers and healthcare providers who have this specific product should stop using it and contact Zimmer, Inc. for instructions on how to return the product.
The recalled product
- Product
- Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Dental implant component.
- Manufacturer
- Zimmer, Inc.
- Category
- Medical Device — Dental Implant
- Hazard
- Affected units
- 291
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 (1)
- Lot No. 62552804
Distribution
Distributed nationwide across the United States.
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