CLASS II Device recall · Reported 8 Feb 2017 · FDA Enforcement Report

SwishTapered Implant recalled by Implant Direct Sybron

Implant Direct Sybron Manufacturing is recalling SwishTapered Implant, distributed in California, Maine, New Mexico, Ohio, Oregon, Texas. The recall was initiated on 12 Dec 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes933308 Lot # 73241

Quantity recalled17

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-1112-2017
FDA event ID: 76111
Recalling firm: Implant Direct Sybron Manufacturing, Westlake Village, CA
Classification: Class II
Status: Terminated
Recall initiated: 12 Dec 2016
FDA classified: 28 Jan 2017
Reported: 8 Feb 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Other Medical Devices

Timeline

12 Dec 2016	Recall initiated by company
28 Jan 2017	Classified by FDA	+47 days
8 Feb 2017	Published in enforcement report	+11 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 product code (9037-03) that is packaged with the SwishTapered (Part Number 933308; Lot Number 73241) Implant was packaged in the incorrect position. This discrepancy may lead to the possibility of extender not seating properly on the implant, which may lead to micro-leakage and a possible infection to the patient.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

SwishTapered Implant

Where it was distributed

U.S. distribution to the following; NM, TX, CA, OR, OH, ME. Foreign distribution to the following; Netherlands.

California Maine New Mexico Ohio Oregon Texas

Questions about this recall

Is SwishTapered Implant recalled?

Yes. Implant Direct Sybron Manufacturing recalled SwishTapered Implant on 12 Dec 2016. The recall is Class II and its status is Terminated. Recall number Z-1112-2017.

Why was it recalled?

Which lots are affected?

933308 Lot # 73241

Where was it sold?

U.S. distribution to the following; NM, TX, CA, OR, OH, ME. Foreign distribution to the following; Netherlands.

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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