Lower riskMedical device recall · FDA · Published January 19, 2018
SwishPlus Implant Recall: Incorrect Packaging May Cause Misuse
Implant Direct recalls SwishPlus Implant for potential incorrect packaging that could lead to misuse in dental bridgework. Affected units include specific part numbers and lots.
The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been packaged in the incorrect position (upside down in the plastic retainer).
Take action
Contact the company
📍Recalling firmImplant Direct Sybron Manufacturing, LLC3050 E Hillcrest Dr · Westlake Village, CA 91362-3171
“SwishPlus Implant Recall: Incorrect Packaging May Cause Misuse.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72120-swishplus-implant-recall-incorrect-packaging-may-cause-misuse. Based on FDA recall #Z-1168-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1168-2018%22&limit=1).
Implant Direct Sybron Manufacturing LLC voluntarily recalled SwishPlus Implants on Jan. 19, 2018, after the FDA announced the extender may be packaged upside down in the plastic retainer. The recall affects 1,117 units distributed worldwide.
The extender packaged with the SwishTapered and SwishPlus Implant may have been placed in the incorrect position, specifically upside down within the plastic retainer.
Context
GovInfoNow's records show Implant Direct Sybron Manufacturing LLC has had 20 other recalls on record since June 26, 2017. Other recent recalls of similar products include Straumann GM Helix Dental Implant Recall (July 13, 2026), ConMed Suture Anchor Recall (July 14, 2026), and Straumann Dental Implant Abutments Recall (March 27, 2026).
How to tell if you have this one
Check the product label for part numbers: 924108, 924112, 924116, 924806, 924810W, 924812W, or 924814. The recall includes specific lots and production dates.
Brand
Implant Direct
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Worldwide Distribution -- US, Europe, Canada, Australia, and Japan.
Recall number
Product, codes & lots
Z-1167-2018
SwishTapered Implant Intended for use in support for fixed bridgework.; Part No. (Lot No.): 934106 (68075, 69252, 79574), 934112 (69101, 80912), 934806 (68076, 75219), 934812 (68078, 68889), 934814 (67980), and 935712 (68077).
Z-1168-2018
SwishPlus Implant Intended for use in support for fixed bridgework.; Part No. (Lot No.): 924108 (97347), 924112 (64927, 93563, 98662), 924116 (70543), 924806 (99749), 924810W (93934), 924812W (94204), and 924814 (103199).
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for part numbers listed in the recall: 924108, 924112, : 924116, 924806, 924810W, 924812W, or 924814.
How this recall unfolded
Recall timeline
FDA terminated this recall 5.5 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-1168-2018 (January 19, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1168-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 31, 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.