Zimmer Dental Implants Recalled for Omitted Instructions in Manual
Zimmer Dental Inc. is recalling specific Trabecular Metal dental implants because critical safety information was missing from the instruction manual.
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, which typically indicates a situation where use may cause temporary or medically reversible health consequences. The specific hazard is a documentation error (omitted information in the IFU) rather than a physical defect or contamination, aligning with the 'Moderate' severity criteria for labeling/documentation issues.
Plain-English summary
Zimmer Dental Inc. is recalling 1,050 units of IMPLANT, MTX 3.7 mm x 10 mm diameter 3.5 mm dental implants (Catalog #TMMB10). The recall is due to a documentation 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 missing information was located in the Indications, Contraindications, and Precautions sections.
The affected units were distributed worldwide, including in the United States and various international markets. The specific lot numbers involved in this recall are 63193919 and 63212189. These implants are designed for use in the maxilla or mandible to replace missing teeth.
Consumers and healthcare providers should check their inventory for the specific catalog number and lot numbers listed above. If the affected units are found, they should be removed from use and returned to the manufacturer or the supplier in accordance with the recall instructions.
The recalled product
- Product
- IMPLANT,TM, MTX 3.7 mm x 10 mm diameter 3.5 mm Catalog #TMMB10 Product 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 more missing
- Manufacturer
- Zimmer Dental Inc
- Category
- Medical Device — Dental Implants
- Affected units
- 1,050
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 # 63193919 63212189
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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