Zimmer Dental Implants Recalled for Missing Instructions
Zimmer Dental Inc. is recalling specific dental implants because the latest instructions omitted information for certain models.
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: This is a Class II recall involving a labeling/instruction error (omitted information in the IFU) without reported injuries or illnesses, fitting the criteria for minor labeling errors or low-risk issues.
Plain-English summary
Zimmer Dental Inc. is recalling 1,059 units of IMPLANT, MTX 4.1 mm x 10 mm diameter 3.5 mm dental implants (Catalog #TMM4B10). The recall involves Lot # 63192993 and Lot # 63216163. These implants are designed for use in the maxilla or mandible to replace missing teeth.
The recall was initiated because information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable Instructions for Use (IFU). Specifically, the Indications, Contraindications, and Precautions sections were incomplete for these models.
The affected products were distributed worldwide, including in the United States (nationwide, including Puerto Rico) and in Thailand, France, Germany, Colombia, Hungary, Netherlands, Saudi Arabia, Poland, Spain, and Italy. Healthcare providers should contact Zimmer Dental Inc. for further instructions regarding the affected lots.
The recalled product
- Product
- IMPLANT,TM, MTX 4.1 mm x 10 mm diameter 3.5 mm Catalog #TMM4B10 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or…
- Manufacturer
- Zimmer Dental Inc
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 1,059
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 (1)
- Lot # 63192993 63216163
Distribution
Part of a larger recall action
This product is one of 13 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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