Implant Direct Recalls SwishTapered Implants Due to Packaging Error
Implant Direct Sybron Manufacturing is recalling 17 SwishTapered Implants because the packaged extender was in the incorrect position, which may cause micro-leakage and infection.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (infection) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Implant Direct Sybron Manufacturing, LLC is recalling 17 units of the SwishTapered Implant (Part Number 933308; Lot Number 73241). The recall is due to a packaging error where the extender product code (9037-03) was packaged in the incorrect position.
This discrepancy may lead to the possibility of the extender not seating properly on the implant. If the extender does not seat properly, it may lead to micro-leakage and a possible infection to the patient.
The affected products were distributed in the United States to New Mexico, Texas, California, Oregon, Ohio, and Maine, as well as to the Netherlands. The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled units.
The recalled product
- Product
- SwishTapered Implant
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 17
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)
- 933308 Lot # 73241
Distribution
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