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.
What this means for you
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
Related recalls
Same manufacturer · Implant Direct Sybron Manufacturing, LLC
See all →- ModerateSterilizable Drill Stop Kits were shipped containing incorrect components
FDA (Devices) · 2025-08-06
- HighDental Implant Abutments Recalled Due to Lack of FDA Clearance
FDA (Devices) · 2023-07-05
- HighDental implant recalled due to size mismatch with labeling
FDA (Devices) · 2021-11-10
- HighDental implants recalled for size mismatch with package labeling
FDA (Devices) · 2021-11-10
- ModerateImplant Direct Legacy 3 Implants Recalled for Incorrect Cover Screws
FDA (Devices) · 2020-02-19
Same hazard · infection
See all →- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
- HighV-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19