Implantech Recalls Terino Square Chin-Style II-Medium Implants
Implantech Associates Inc is voluntarily recalling 8 units of Terino Square Chin-Style II-Medium implants because they do not meet dimensional requirements.
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 a voluntary precautionary action for a non-conformance to dimensional requirements with no reported injuries or illnesses, fitting the criteria for a moderate severity rating.
Plain-English summary
Implantech Associates Inc has initiated a voluntary recall of 8 units of Terino Square Chin-Style II-Medium implants, catalog number TSCII-M. The affected units are from lot numbers 848488 and 850156. These medical devices are intended to augment or reconstruct underdeveloped or traumatized mandibular regions.
The recall was initiated after the manufacturer determined that the devices from these specific lots do not conform to the required dimensional specifications for the TSCII-M model. The source text does not report any illnesses, injuries, or deaths associated with the use of these devices.
The affected products were distributed worldwide, including nationwide in the United States (specifically noting New York, Kentucky, and Colorado) and in Israel. Consumers and healthcare providers should stop using these specific lots and contact the manufacturer for further instructions.
The recalled product
- Product
- Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. To augment or reconstruct underdeveloped or traumatized mandibular region.
- Manufacturer
- Implantech Associates Inc
- Category
- Medical Device — Implants
- Affected units
- 8
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)
- Catalog Number: TSCII-M Lot Numbers: 848488 and 850156
Distribution
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