Use cautionMedical device recall · FDA · Published January 9, 2019
SwishPlus Implant 5.7mmD x 8mmL: Incorrect Color Coding May Cause Surgical Errors
Implant Direct recalls SwishPlus Implant 5.7mmD x 8mmL due to incorrect color coding on vials and caps, potentially causing surgical errors. Affected units have specific part numbers and were not distributed in the US.
Due to a complaint received and internal investigation it was determined that implant vials were distributed with incorrect color coded vials and caps. The part/lot numbers were correct, the customer received the product they ordered, however the color on the vial label and cap labels were incorrect.Specifically, the color coded vial and cap does not match the implant size described on the vial. As a result of the incorrect color on the vial and cap, the surgeon may not be certain if the implant received was the correct size. This could result in a delay in surgery, risk of infection if the surgical site has to be closed up and a second round of anesthesia.
Take action
Contact the company
📍Recalling firmImplant Direct Sybron Manufacturing LLC3050 E Hillcrest Dr · Westlake Village, CA 91362-3171
“SwishPlus Implant 5.7mmD x 8mmL: Incorrect Color Coding May Cause Surgical Errors.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69147-swishplus-implant-5-7mmd-x-8mml-incorrect-color-coding-may. Based on FDA recall #Z-1126-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1126-2020%22&limit=1).
Implant Direct Sybron Manufacturing LLC recalled SwishPlus Implants due to incorrect color-coded vials and caps that may cause surgeons to doubt implant size, the FDA said on Jan. 9, 2019.
How to tell if you have it
Brand: Implant Direct
Product: SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform
Part Number: 925708
Lot #: 109038
The hazard
The recall involves implant vials distributed with incorrect color-coded vials and caps where the color does not match the implant size described on the vial. This discrepancy could result in a delay in surgery, risk of infection if the surgical site has to be closed up and a second round of anesthesia.
Context
GovInfoNow's records show Implant Direct Sybron Manufacturing LLC has 20 other recalls on record since June 26, 2017. Other recent recalls of similar products include Sybron Drill Stop Kit Recall (May 1, 2025), Sybron Legacy Smartbase Recalls (May 2, 2023), ImplantDirect Legacy 2 dental implants recalled for incorrect size labeling (Sept. 23, 2021), Micro Therapeutics Pipeline Flex Embolization Device: Incorrect Labeling Risk (June 8, 2026), Micro Therapeutics Pipeline Flex Embolization Device Labeling Error (June 8, 2026), and DT MedTech Hintermann Talar Implant Left Size 2: Incorrect Left/Right Labeling (March 24, 2026).
How to tell if you have this one
Check for SwishPlus Implant 5.7mmD x 8mmL with part number 925708. The color on the vial and cap labels does not match the implant size described. No units were distributed in the US.
Brand
Implant Direct
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Verify Product Details
Check the vial and cap color codes against the implant size listed on the vial to ensure they match.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1126-2020 (January 9, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1126-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.