Zimmer Dental Implants Recalled for Missing Safety Information in Instructions
Zimmer Dental Inc is recalling specific dental implants because the instructions for use omitted safety information regarding the 3.7 mmD and 4.1 mmD Trabecular Metal 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: The recall is classified as FDA Class II, but the source text explicitly states that the issue is the omission of information from the Instructions for Use, with no reported illnesses or injuries. This aligns with the rubric for moderate severity involving labeling or documentation issues.
Plain-English summary
Zimmer Dental Inc is recalling 1,059 units of IMPLANT, MTX FULL 4.1 mm x 10 mm diameter 3.5 mm dental implants. The recall affects specific lots: 63187148, 63192992, 63212188, and 63216161. The products were distributed worldwide, including in the United States and various international locations.
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 missing this data. This is an FDA Class II recall.
Healthcare providers and patients who have received these implants should contact Zimmer Dental Inc for further instructions. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- IMPLANT,TM, MTX FULL 4.1 mm x 10 mm diameter 3.5 mm Catalog #TMT4B10 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 # 63187148 63192992 63212188 63216161
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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