Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0774-2016·Announced 2016-02-17

Zimmer Dental Implants Recalled for Omitted Safety Information in Instructions

Zimmer Dental Inc. is recalling specific Trabecular Metal 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 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 corresponds to a Moderate severity score (2) when the issue is a labeling or documentation error rather than a direct physical defect causing injury.

Plain-English summary

Zimmer Dental Inc. is recalling 1,050 units of IMPLANT, MTX 4.1 mm x 13 mm diameter 3.5 mm dental implants. The recall affects specific lots identified as 63203121, 63207952, and 63216164. These products were distributed worldwide, including in the United States and various international markets.

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, the Indications, Contraindications, and Precautions sections did not include the required details for these specific implant sizes.

This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. Consumers and healthcare providers should contact Zimmer Dental Inc. for further instructions regarding the affected implants.

The recalled product

Product: IMPLANT,TM, MTX 4.1 mm x 13 mm diameter 3.5 mm Catalog #TMM4B13 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: mis-labeling
documentation-error
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 # 63203121 63207952 63216164

Distribution

Distributed nationwide across the United States.

The notice also names 31 states specifically:

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 →

Same manufacturer · Zimmer Dental Inc

See all →

Low
Zimmer Dental Implants Recalled for Incorrect Inner Package Labeling
FDA (Devices) · 2018-09-12
Moderate
Zimmer Dental Recalls Tapered Screw-Vent Implants Due to Labeling Error
FDA (Devices) · 2018-04-04
Moderate
Zimmer Dental Recalls Tapered Screw-Vent Implants Due to Mislabeled Lots
FDA (Devices) · 2018-04-04
Moderate
Zimmer Dental Tapered Screw-Vent MTX Implant Vial Caps Recalled for Cracking
FDA (Devices) · 2017-12-27
High
Zimmer Dental Surgical Kits Recalled for Manufacturing Defect
FDA (Devices) · 2017-12-27

Same hazard · mis labeling