Southern Implants Recalls Dental Implants Due to Inner Labeling Error
Southern Implants is recalling 49 dental implant units because the inner label incorrectly identifies the product reference number.
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 and labeling issue (incorrect inner label text) with no reported injuries, illnesses, or functional defects in the medical device.
Plain-English summary
Southern Implants, (Pty.) Ltd. is recalling 49 units of the SOUTHERN IMPLANTS REF IBR12d-13 dental implant. The product is intended for surgical placement in the upper or lower jaw to support prosthetic attachments such as crowns, bridges, or overdentures.
The recall was initiated because the inner label on the product incorrectly reads IBNT12d-13, while the UDI label correctly reads IBR12d-13. This discrepancy is a labeling error that does not indicate a defect in the implant's physical structure or material composition.
The affected units are identified by lot code 251J00d2. The recall distribution includes the United States, South Africa, and France. Consumers and healthcare providers should verify the labeling on their inventory and contact the manufacturer for further instructions regarding the affected units.
The recalled product
- Product
- SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading.
- Manufacturer
- Southern Implants, (Pty.) Ltd.
- Category
- Medical Device — Dental Implant
- Hazard
- Affected units
- 49
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 code: 251J00d2
Distribution
Distribution scope not specified by the agency.
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