Zimmer Dental Implants Recalled for Omitted Safety Information in Instructions
Zimmer Dental Inc is recalling specific dental implants because safety information was omitted from the 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 FDA Class II and involves a labeling error where safety information was omitted from the instructions for use. This fits the rubric for moderate severity, as it is a labeling issue without reported injuries or illnesses.
Plain-English summary
Zimmer Dental Inc is recalling 1,059 units of IMPLANT, MTX 3.7 mm x 11.5 mm diameter 3.5 mm (Catalog #TMMB11) dental implants. The recall is due to a labeling error where specific information regarding the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the Instructions for Use (IFU).
The omitted information was located in the Indications, Contraindications, and Precautions sections of the IFU. The affected products were distributed worldwide, including in the United States and various international locations. The specific lot number for the recalled items is 63212190.
Healthcare providers and patients should contact Zimmer Dental Inc for further instructions on how to proceed with the recalled devices.
The recalled product
- Product
- IMPLANT,TM, MTX 3.7 mm x 11.5 mm diameter 3.5 mm Catalog #TMMB11 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 # 63212190
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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