Zimmer Dental Implants Recalled for Omitted Safety Information in Instructions
Zimmer Dental Inc. is recalling specific Trabecular Metal implants because safety information was omitted from the instructions for use.
What this means for you
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 minor labeling error where safety information was omitted from the instructions, fitting the criteria for moderate severity.
Plain-English summary
Zimmer Dental Inc. is recalling 1,059 units of IMPLANT, MTX FULL 3.7 mm x 10 mm diameter 3.5 mm (Catalog #TMTB10) dental implants. The recall is due to a labeling error where 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) in the Indications, Contraindications, and Precautions sections.
The affected products were distributed worldwide, including in the United States and various international locations. The specific lot numbers involved are 63193918 and 63223934. These implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period to replace missing teeth.
Consumers and healthcare providers should contact Zimmer Dental Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- IMPLANT,TM, MTX FULL 3.7 mm x 10 mm diameter 3.5 mm Catalog #TMTB10 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 # 63193918 63223934
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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