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.
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, 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…
- 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.
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 · documentation error
See all →- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- LowMindray cPM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
- LowMindray Recalls Passport Series Patient Monitor Operator's Manuals
FDA (Devices) · 2026-10-14
- ModerateConMed Suture Anchor Recalled for Incorrect Patient Implant Card
FDA (Devices) · 2026-09-02
- ModerateHenry Schein Recalls Structur 2 SC Temporary Resin Cartridges for Incorrect Packaging
FDA (Devices) · 2026-09-02
Similar recalls
- LowZimmer Dental Recalls Implants Due to Missing Supplemental Instructions
FDA (Devices) · 2017-10-04
- ModerateZimmer Dental Recalls Spline Twist Implants Due to Labeling Error
FDA (Devices) · 2014-11-05
- LowZimmer Dental Implants Recalled for Incorrect Inner Package Labeling
FDA (Devices) · 2018-09-12
- LowZimmer Dental Recalls Impression Caps Due to Missing Supplemental Instructions
FDA (Devices) · 2017-10-04
- ModerateZimmer Dental Recalls Tapered Screw-Vent Implants Due to Labeling Error
FDA (Devices) · 2014-11-05
- ModerateZimmer Dental Implant Surgical Kits Recalled for Manufacturing Defect
FDA (Devices) · 2017-12-27