Zimmer Dental Implants Recalled for Omitted Safety Information in Instructions
Zimmer Dental Inc. is recalling specific dental implants because safety information was missing from the instructions for use.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it involves a documentation issue (omitted information in the IFU) with no reported injuries or illnesses, fitting the rubric criteria for packaging or documentation-only problems.
Plain-English summary
Zimmer Dental Inc. is recalling 1,059 units of IMPLANT, MTX FULL 3.7 mm x 16 mm diameter 3.5 mm dental implants (Catalog #TMTB16, Lot #63192173). The recall is due to a documentation error where information specific to 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 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.
Healthcare professionals and patients should contact Zimmer Dental Inc. for further instructions regarding the use of these specific implants.
The recalled product
- Product
- IMPLANT,TM, MTX FULL 3.7 mm x 16 mm diameter 3.5 mm Catalog #TMTB16 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 # 63192173
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
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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
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