Zimmer Dental Recalls Tapered SwissPlus Implant System Due to Thread Defect
Zimmer Dental Inc is recalling 188 units of the Tapered SwissPlus Implant System because the internal thread diameter is below specification.
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 describes a manufacturing defect without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Dental Inc is recalling 188 units of the Tapered SwissPlus Implant System, Model No. SPB10. The recall is due to a manufacturing defect where the minor diameter of the internal thread is below specification.
The affected units are identified by Lot #63498673 and UDI (01) 008890240177 (10) 63498673 (17) 200731. The distribution pattern for these units is listed as worldwide, specifically mentioning ZA, FR, IT, and IR.
Consumers and healthcare providers should check their inventory for the specific lot number and UDI listed above. If the product is found, it should be removed from use and returned to the manufacturer or authorized distributor in accordance with the recall instructions.
The recalled product
- Product
- Tapered SwissPlus Implant System, Model No. SPB10
- Manufacturer
- Zimmer Dental Inc
- Category
- Medical Device — Dental Implant
- Hazard
- Affected units
- 188
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 #63498673
- UDI: (01) 008890240177 (10) 63498673 (17) 200731
Distribution
Distribution scope not specified by the agency.
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