CLASS II Device recall · Reported 27 Dec 2017 · FDA Enforcement Report

Tapered SwissPlus & SwissPlus Implant Systems surgical kit recalled

Zimmer Dental is recalling Tapered SwissPlus & SwissPlus Implant Systems surgical kit, distributed nationwide in the US. The recall was initiated on 11 Oct 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot numbers 63666559 and 63705907

Quantity recalled30 kits

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-0280-2018
FDA event ID: 78321
Recalling firm: Zimmer Dental, Carlsbad, CA
Classification: Class II
Status: Terminated
Recall initiated: 11 Oct 2017
FDA classified: 21 Dec 2017
Reported: 27 Dec 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

11 Oct 2017	Recall initiated by company
21 Dec 2017	Classified by FDA	+71 days
27 Dec 2017	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 device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.

Product as listed by the FDA

Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit, Ref OPCST. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour.

Where it was distributed

Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, Belgium, Bulgaria, Chile, Costa Rica, Egypt, France, Georgia, Germany, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Japan, Lebanon, Lithuania, Netherlands, Nicaragua, Poland, Portugal, Romania, Serbia, Shanghai, Spain, Taiwan, Thailand, Tunisia, Turkey, UK, and United Arab Emirates.

Nationwide Georgia

Questions about this recall

Why was it recalled?

The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.

Which lots are affected?

Lot numbers 63666559 and 63705907

Where was it sold?

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

Other products in this recall event

3 other products · FDA event 78321

This product is part of a recall event; the main page for the event is GemLock RHD2.5 Hex Driver recalled by Zimmer Dental.

Reported	Class	Recall	Company	Reason	Where
27 Dec 2017	CLASS II	GemLock RHD2.5 Hex Driver recalled by Zimmer Dental	Zimmer Dental	Other	Nationwide
27 Dec 2017	CLASS II	Instrument Kit System, Tapered Screw-Vent Implant System recalled	Zimmer Dental	Other	Nationwide
27 Dec 2017	CLASS II	Instrument Kit System, Tapered Screw-Vent Implant System recalled	Zimmer Dental	Other	Nationwide

More recalls from Zimmer Dental

All 33

Reported	Class	Recall	Company	Reason	Where
12 Sep 2018Device	CLASS II	Outer Package Label: Tapered Screw-Vent Implant System recalled	Zimmer Dental	Packaging Defects	Nationwide
4 Apr 2018Device	CLASS II	Tapered Screw-Vent MTX, Dental Implant, sterile recalled	Zimmer Dental	Labeling Errors	Nationwide
4 Apr 2018Device	CLASS II	Tapered Screw-Vent MTX, Dental Implant, sterile recalled	Zimmer Dental	Labeling Errors	Nationwide
27 Dec 2017Device	CLASS II	Instrument Kit System, Tapered Screw-Vent Implant System recalled	Zimmer Dental	Other	Nationwide
27 Dec 2017Device	CLASS II	Instrument Kit System, Tapered Screw-Vent Implant System recalled	Zimmer Dental	Other	Nationwide

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All 3,809

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2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Other	Nationwide