Zimmer Dental Recalls Tapered Screw-Vent Implants Due to Labeling Error
Zimmer Dental Inc is recalling Tapered Screw-Vent MTX dental implants because two lots were inadvertently commingled during manufacturing, potentially resulting in mislabeling.
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 source text identifies the issue as a labeling error due to commingling without reporting any injuries, illnesses, or specific safety hazards beyond the mislabeling itself, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Zimmer Dental Inc is recalling Tapered Screw-Vent MTX, Dental Implant, sterile, Model TSVTB10. The recall involves 995 distribution events and covers products distributed worldwide, including the US, Canada, Chile, Costa Rica, Denmark, France, Hungary, Italy, Japan, Lebanon, Portugal, Serbia, Spain, and Taiwan.
The recall was initiated because two lots of the implants, which have different outer thread diameters, were inadvertently commingled during the manufacturing process. As a result, the products may be mislabeled. The specific lot number identified is 63621027, with UDI (01)00889024019928 (17)220331 (10)63619437.
Healthcare providers and consumers should check their inventory for this specific model and lot number. If the product is found, it should be removed from use and returned to the manufacturer or the distributor from whom it was purchased.
The recalled product
- Product
- Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10.
- Manufacturer
- Zimmer Dental Inc
- Category
- Medical Device — Dental Implant
- Hazard
- Affected units
- 995
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. 63621027
- UDI #(01)00889024019928 (17)220331 (10)63619437.
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.
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Similar recalls
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