Zimmer Dental Implants Recalled for Omitted Safety Information in Instructions
Zimmer Dental Inc is recalling specific Trabecular Metal dental implants because safety information was missing 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 a documentation error (omitted information in the IFU) rather than a physical defect or contamination, fitting the 'Moderate' criteria for minor labeling/documentation issues.
Plain-English summary
Zimmer Dental Inc is recalling 1,059 units of IMPLANT, MTX FULL 3.7 mm x 13 mm diameter 3.5 mm dental implants (Catalog #TMTB13). The recall involves specific lots (63193921 and 63236806) distributed worldwide, including in the United States and various international markets.
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, this information was missing from the Indications, Contraindications, and Precautions sections. The implants are designed for use in the maxilla or mandible for immediate loading or loading after a conventional healing period.
Healthcare providers and patients who have received these specific implants should contact Zimmer Dental Inc for further instructions on how to proceed. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- IMPLANT,TM, MTX FULL 3.7 mm x 13 mm diameter 3.5 mm Catalog #TMTB13 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…
- 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 # 63193921 63236806
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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Similar recalls
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