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.
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 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.
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