Zimmer Dental Recalls Tapered Screw-Vent Implants Due to Labeling Error
Zimmer Dental is recalling specific Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.
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, but the hazard is a minor labeling error (incorrect diameter size on the vial) with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer Dental Inc is recalling 1,044 units of Tapered Screw-Vent Implants, specifically the MTX 4.1mmD X 10mmL X 3.5mm Platform (Part No. TSV4B10) and MTX 4.1mmD X 11.5mmL X 3.5mm Platform (Part No. TSV4B11). The recall is due to a labeling error where the incorrect diameter size was printed on the inner vial.
The affected implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period to replace one or more missing teeth. The recall covers Lot No. 62659204 and 62658448. These products were distributed nationwide in the United States as well as in Poland, Canada, Belgium, Italy, France, Israel, Morocco, Spain, Costa Rica, and Japan.
Healthcare providers and patients should verify the lot numbers and part numbers of their implants against this recall notice. If the products match the recalled specifications, they should contact Zimmer Dental Inc for further instructions on how to proceed.
The recalled product
- Product
- Tapered Screw-Vent Implant, MTX, 4.1mmD X 10mmL X 3.5mm Platform Part No. TSV4B10 Tapered Screw-Vent Implant, MTX, 4.1mmD X 11.5mmL X 3.5mm Platform Part No. TSV4B11 The Tapered Screw-Vent Implants are designed for use in the maxilla or mandible for immediate loading or…
- Manufacturer
- Zimmer Dental Inc
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 1,044
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)
- Lot No. 62659204
- 62658448
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
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Similar recalls
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FDA (Devices) · 2018-09-12
- ModerateZimmer Dental Recalls Tapered Screw-Vent Implant Lot Due to Labeling Error
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