Implant Direct Sybron Recalls Dental Implants With Incorrect Color Coding
Implant Direct Sybron Manufacturing LLC is recalling 11 dental implant units because the vial and cap colors did not match the implant size, potentially causing surgical delays or infection risks.
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 risk-of-harm product (medical device) where injury (infection, anesthesia risk) has not yet been reported, fitting the 'High' severity criteria for theoretical or unreported harm.
Plain-English summary
Implant Direct Sybron Manufacturing LLC is recalling 11 units of SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708. The recall was initiated after a complaint and internal investigation revealed that the implant vials were distributed with incorrect color-coded vials and caps. While the part and lot numbers were correct and customers received the specific product they ordered, the color on the vial label and cap labels did not match the implant size described on the vial.
The incorrect color coding could prevent surgeons from being certain that the implant received was the correct size. This discrepancy could result in a delay in surgery, a risk of infection if the surgical site has to be closed up, and the need for a second round of anesthesia. The affected devices were distributed in Iceland, Sweden, and Spain; no affected devices were distributed within the United States.
The recalled product
- Product
- SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708
- Manufacturer
- Implant Direct Sybron Manufacturing LLC
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 11
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 # 109038 No affected devices distributed within the US.
Distribution
Distribution scope not specified by the agency.
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 · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
Similar recalls
- HighImplant Direct Recalls SwishTapered Implants Due to Packaging Error
FDA (Devices) · 2017-02-08
- ModerateImplant Direct Dental Implants Recalled for Incorrect Cap Labeling
FDA (Devices) · 2018-05-30
- ModerateSwishPlus Implant Extender Packaging Error Recall
FDA (Devices) · 2018-03-28
- ModerateImplant Direct Sybron Recalls Mislabeled Dental Implant Vials
FDA (Devices) · 2019-10-09
- LowImplantDirect Dental Implants Recalled for Incorrect Vial Label Part Number
FDA (Devices) · 2018-08-01
- ModerateImplant Direct Recalls Swish Duo-Grip Healing Collars Due to Wrong Component
FDA (Devices) · 2017-10-11