Zimmer Dental Implants Recalled for Omitted Safety Information in Instructions
Zimmer Dental Inc. is recalling specific Trabecular Metal dental implants because safety information was omitted from the latest instructions for use.
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 Moderate because it involves a documentation and labeling error (omitted safety information) without reported injuries or illnesses, fitting the criteria for minor labeling errors or voluntary precautionary recalls.
Plain-English summary
Zimmer Dental Inc. is recalling 1,059 units of IMPLANT, MTX FULL 4.1 mm x 11.5 mm diameter 3.5 mm dental implants (Catalog #TMT4B11). The recall involves specific lots: 63192990, 63203112, and 63236810. 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, details regarding Indications, Contraindications, and Precautions were missing from the documentation.
The affected products were distributed worldwide, including nationwide in the United States and in several international countries. The source text does not report any illnesses or injuries associated with this recall. Consumers and healthcare providers should refer to the updated instructions for use provided by the manufacturer to ensure safe and appropriate implant placement.
The recalled product
- Product
- IMPLANT,TM, MTX FULL 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMT4B11 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…
- Manufacturer
- Zimmer Dental Inc
- Category
- Medical Device — Dental Implants
- 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 # 63192990 63203112 63236810
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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Similar recalls
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