Southern Implants Recalls Dental Implants Due to Labeling Mismatch
Southern Implants, Inc. is recalling 130 units of MAX-TL and Z-MAX dental implants because the labeled packages contained the wrong implant type.
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 corresponds to a Moderate severity score. The hazard is a labeling error where the wrong product type was placed in the package, which is a significant quality issue but does not involve a high-risk pathogen or immediate life-threatening defect.
Plain-English summary
Southern Implants, Inc. is recalling 130 units of MAX-TL 9.0 x 7.0 mm Implants (Catalog No. 15711K) and Z-MAX Implants 9.0 x 7 mm Length (Catalog No. Z-MAX9-7). The recall is due to a labeling error where packages labeled as Z-MAX implants contained MAX-TL implants, and packages labeled as MAX-TL implants contained Z-MAX implants.
The affected products are dental implants intended to be implanted in the upper and lower jaw arches to provide support for fixed or removable dental prostheses. The recall covers units distributed nationwide in the United States. The specific lots affected are MAX-TL Lot# 1244041400 and Z-MAX9-7 Lot# 1238041402.
Consumers and healthcare providers should check their inventory for these specific catalog numbers and lot numbers. If these products are found, they should be removed from use and returned to the manufacturer or the distributor from whom they were purchased.
The recalled product
- Product
- MAX-TL 9.0 x 7.0 mm Implant, Catalog No. 15711K; Z-MAX Implant 9.0 x 7 mm Length, Catalog No. Z-MAX9-7. Dental implant. Product Usage: The MAX Implant is intended to be implanted in the upper and lower jaw arches to provide support for fixed or removable dental prostheses…
- Manufacturer
- Southern Implants, Inc
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 130
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)
- MAX-TL Lot# 1244041400 Z-MAX9-7 Lot# 1238041402
Distribution
Distributed nationwide across the United States.
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