Zimmer Dental Tapered Screw-Vent MTX Implant Vial Caps Recalled for Cracking
Zimmer Dental Inc is recalling 500 units of Tapered Screw-Vent MTX Model TSVTB11 implants because some vial caps may crack due to a manufacturing assembly condition.
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 the hazard involves a manufacturing defect (cracking caps) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Dental Inc is recalling 500 units of the Tapered Screw-Vent MTX Model TSVTB11 dental implant. The recall is due to a manufacturing assembly condition that may cause some implant vial caps to inadvertently crack.
The affected product is identified by lot number 63519794 and UDI (01)00889024019935 (17)211130 (10)63519794. The product was distributed in the United States, Canada, France, Italy, Spain, and Germany.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with the defect.
The recalled product
- Product
- Tapered Screw-Vent MTX Model TSVTB11
- Manufacturer
- Zimmer Dental Inc
- Category
- Medical Device — Dental Implants
- Affected units
- 500
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 (3)
- lot
- #63519794
- UDI: (01)00889024019935 (17)211130 (10)63519794
Distribution
Distribution scope not specified by the agency.
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