CLASS II Device recall · Reported 20 Nov 2019 · FDA Enforcement Report

Implant Direct recalled

Implant Direct Sybron Manufacturing is recalling Implant Direct, distributed in Indiana, Maryland, Texas, Virginia, Washington. The recall was initiated on 9 Aug 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #135128 Exp: 3/12/20

Quantity recalled23 implants

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-0364-2020
FDA event ID: 83763
Recalling firm: Implant Direct Sybron Manufacturing, Westlake Village, CA
Classification: Class II
Status: Terminated
Recall initiated: 9 Aug 2019
FDA classified: 12 Nov 2019
Reported: 20 Nov 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Dental Devices

Timeline

9 Aug 2019	Recall initiated by company
12 Nov 2019	Classified by FDA	+95 days
20 Nov 2019	Published in enforcement report	+8 days

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

Reason for recall

A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants

Where it was distributed

U.S.: IN, VA, MD, TX, WA OUS: Japan

Indiana Maryland Texas Virginia Washington

Questions about this recall

Why was it recalled?

A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered.

Which lots are affected?

Lot #135128 Exp: 3/12/20

Where was it sold?

U.S.: IN, VA, MD, TX, WA OUS: 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 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.

More recalls from Implant Direct Sybron Manufacturing

All 33

Reported	Class	Recall	Company	Reason	Where
6 Aug 2025Device	CLASS II	The Drill Stop Kit recalled by Implant Direct Sybron	Implant Direct Sybron Manufacturing	Other	Nationwide
5 Jul 2023Device	CLASS II	Legacy Smartbase, Ne 3.0d 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 5.7mmD x 8mmL, SBM 6.5mmD Platform recalled	Implant Direct Sybron Manufacturing	Device Malfunction	CA

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15 Jul 2026Device	CLASS II	KL Owen Custom Orthodontic Solution recalled by Klowen Braces	Klowen Braces	Device Malfunction	Nationwide
6 May 2026Device	CLASS II	Straumann n!ce PMMA Full-arch Restoration recalled	Straumann USA	Other	8 states
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