CLASS II ONGOING Device recall · Reported 10 Nov 2021 · FDA Enforcement Report

ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD recalled

Implant Direct Sybron Manufacturing is recalling ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD, distributed nationwide in the US. The recall was initiated on 23 Sep 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codeslot # 166297 / UDI: 10841307101789

Quantity recalled61 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-0197-2022
FDA event ID: 88859
Recalling firm: Implant Direct Sybron Manufacturing, Westlake Village, CA
Classification: Class II
Status: Ongoing
Recall initiated: 23 Sep 2021
FDA classified: 3 Nov 2021
Reported: 10 Nov 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

23 Sep 2021	Recall initiated by company
3 Nov 2021	Classified by FDA	+41 days
10 Nov 2021	Published in enforcement report	+7 days

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

Reason for recall

Packaged dental implant contains a different size then the size declared on the labeling.

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

ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,

Where it was distributed

Worldwide distribution - US Nationwide distribution in the states of AZ, CA, HI, IL, KS, LA, MA, MD, MI, MO, MT, NE, NJ, NY, OH, OR, PA, RI, SC, TX, UT, VA, WA, WI and the country of Japan.

Nationwide Arizona California Hawaii Illinois Kansas Louisiana Massachusetts Maryland Michigan Missouri Montana Nebraska New Jersey New York Ohio Oregon Pennsylvania Rhode Island South Carolina Texas

Questions about this recall

Why was it recalled?

Packaged dental implant contains a different size then the size declared on the labeling.

Which lots are affected?

lot # 166297 / UDI: 10841307101789

Where was it sold?

Worldwide distribution - US Nationwide distribution in the states of AZ, CA, HI, IL, KS, LA, MA, MD, MI, MO, MT, NE, NJ, NY, OH, OR, PA, RI, SC, TX, UT, VA, WA, WI and the country of 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.

Other products in this recall event

1 other product · FDA event 88859

This product is part of a recall event; the main page for the event is ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD recalled.

Reported	Class	Recall	Company	Reason	Where
10 Nov 2021	CLASS II	ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD recalled	Implant Direct Sybron Manufacturing	Packaging Defects	Nationwide

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 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
19 Feb 2020Device	CLASS II	Implant Direct, CE recalled	Implant Direct Sybron Manufacturing	Packaging Defects	22 states

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