Zimmer Dental Recalls Tapered Screw-Vent Implants Due to Mislabeled Lots
Zimmer Dental Inc is recalling Tapered Screw-Vent MTX dental implants because two lots with different thread diameters were commingled and may be mislabeled.
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 labeling error (commingling/mislabeling) without reported injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Dental Inc is voluntarily recalling Tapered Screw-Vent MTX dental implants, sterile, Model TSV4B10. The recall involves 995 distribution events and includes Lot No. 63619437 with UDI (01)00889024019225 (17)220331 (10)63619437. The products were distributed worldwide, including the United States, 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 implants may be mislabeled. This is an FDA Class II recall, which indicates a situation that may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Healthcare professionals and patients who have received these implants should contact Zimmer Dental Inc for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.
- 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. 63619437
- UDI #(01)00889024019225 (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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