CLASS II Device recall · Reported 28 Mar 2018 · FDA Enforcement Report

SwishPlus Implant Intended for use in support for fixed bridgework recalled

Implant Direct Sybron Manufacturing is recalling SwishPlus Implant Intended for use in support for fixed bridgework. The recall was initiated on 19 Jan 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart No. (Lot No.): 924108 (97347), 924112 (64927, 93563, 98662), 924116 (70543), 924806 (99749), 924810W (93934), 924812W (94204), and 924814 (103199).

Quantity recalled1,117 units total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1168-2018
FDA event ID: 79396
Recalling firm: Implant Direct Sybron Manufacturing, Westlake Village, CA
Classification: Class II
Status: Terminated
Recall initiated: 19 Jan 2018
FDA classified: 22 Mar 2018
Reported: 28 Mar 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

19 Jan 2018	Recall initiated by company
22 Mar 2018	Classified by FDA	+62 days
28 Mar 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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).

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

SwishPlus Implant Intended for use in support for fixed bridgework.

Where it was distributed

Worldwide Distribution -- US, Europe, Canada, Australia, and Japan.

Questions about this recall

Is SwishPlus Implant Intended for use in support for fixed bridgework recalled?

Yes. Implant Direct Sybron Manufacturing recalled SwishPlus Implant Intended for use in support for fixed bridgework on 19 Jan 2018. The recall is Class II and its status is Terminated. Recall number Z-1168-2018.

Why was it 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).

Which lots are affected?

Part No. (Lot No.): 924108 (97347), 924112 (64927, 93563, 98662), 924116 (70543), 924806 (99749), 924810W (93934), 924812W (94204), and 924814 (103199).

Where was it sold?

Worldwide Distribution -- US, Europe, Canada, Australia, and Japan.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Implant Direct Sybron Manufacturing

All 33

Reported	Class	Recall	Company	Reason	Where
6 Aug 2025Device	CLASS II	The Drill Stop Kit is recalled by Implant Direct Sybron	Implant Direct Sybron Manufacturing	Sterility	Nationwide
5 Jul 2023Device	CLASS II	Legacy Smartbase, Ne 0d 1mml recalled by Implant Direct Sybron	Implant Direct Sybron Manufacturing	Other	Nationwide
10 Nov 2021Device	CLASS II	ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD recalled	Implant Direct Sybron Manufacturing	Packaging Defects	Nationwide
10 Nov 2021Device	CLASS II	ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD recalled	Implant Direct Sybron Manufacturing	Packaging Defects	Nationwide
19 Feb 2020Device	CLASS II	SwishPlus Implant 7mmD x 8mmL, SBM 5mmD Platform recalled	Implant Direct Sybron Manufacturing	Device Malfunction	CA

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