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.
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, 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 m
- 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
Same manufacturer · Zimmer Dental Inc
See all →- LowZimmer Dental Implants Recalled for Incorrect Inner Package Labeling
FDA (Devices) · 2018-09-12
- ModerateZimmer Dental Recalls Tapered Screw-Vent Implants Due to Mislabeled Lots
FDA (Devices) · 2018-04-04
- ModerateZimmer Dental Recalls Tapered Screw-Vent Implants Due to Labeling Error
FDA (Devices) · 2018-04-04
- ModerateZimmer Dental Tapered Screw-Vent MTX Implant Vial Caps Recalled for Cracking
FDA (Devices) · 2017-12-27
- HighZimmer Dental Tapered Screw-Vent Implant Surgical Kits Recalled for Geometry Defect
FDA (Devices) · 2017-12-27
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02