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 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, but the hazard is limited to omitted documentation (labeling/instructions) rather than a physical defect or contamination, fitting the 'Moderate' criteria for minor labeling errors.
Plain-English summary
Zimmer Dental Inc. is recalling 1,059 units of IMPLANT, MTX 4.1 mm x 11.5 mm diameter 3.5 mm dental implants (Catalog #TMM4B11). The recall affects specific lots, including 63192991 and 63207953. 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 in the United States and various international markets. Patients who have received these implants should contact their dental provider for guidance regarding the missing safety information.
The recalled product
- Product
- IMPLANT,TM, MTX 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMM4B11 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
- 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 # 63192991 63207953
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.
See all 13 products in this recall →Related recalls
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