Reported Mar 28, 2018 · Terminated
SwishPlus Implant Intended for use in support for fixed bridgework.
Implant Direct Sybron Manufacturing, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Implant Direct Sybron Manufacturing, LLC · 3050 E Hillcrest Dr · Westlake Village, CA · 91362-3171
Is this the product you have?
- SwishPlus Implant Intended for use in support for fixed bridgework.
- Lot codes and dates
Part No. (Lot No.): 924108 (97347)924112 (649279356398662)924116 (70543)924806 (99749)924810W (93934)924812W (94204)and 924814 (103199)
- Amount recalled
- 1,117 units total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Implant Direct Sybron Manufacturing, LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.