Zimmer Dental Implants Recalled for Missing Instructions in Manual
Zimmer Dental Inc is recalling specific Trabecular Metal implants because the latest instruction manual omitted critical safety information for certain sizes.
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 (missing information in the IFU) rather than a physical defect or contamination, and no injuries or illnesses are reported.
Plain-English summary
Zimmer Dental Inc is recalling 1,059 units of IMPLANT, MTX FULL 3.7 mm x 11.5 mm diameter 3.5 mm dental implants. The recall is due to a documentation error where 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). This omission affected the Indications, Contraindications, and Precautions sections of the manual.
The affected products were distributed worldwide, including in the United States and various international markets. The specific lot numbers involved are 63193920 and 63244217. These implants are designed for use in the maxilla or mandible to replace missing teeth.
Healthcare providers and patients should check their records for these specific catalog numbers and lot numbers. If the product is identified, they should contact Zimmer Dental Inc for further instructions on how to proceed.
The recalled product
- Product
- IMPLANT,TM, MTX FULL 3.7 mm x 11.5 mm diameter 3.5 mm Catalog #TMTB11 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 # 63193920 63244217
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
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FDA (Devices) · 2017-10-04
- ModerateZimmer Dental Recalls Spline Twist Implants Due to Labeling Error
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