CLASS II Device recall · Reported 10 Aug 2016 · FDA Enforcement Report

RePlant¿ Angled Abutment recalled by Implant Direct Sybron

Implant Direct Sybron Manufacturing is recalling RePlant¿ Angled Abutment, distributed in 24 states. The recall was initiated on 5 Jul 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #50174, 39799, 49364

Quantity recalled205

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-2320-2016
FDA event ID: 74624
Recalling firm: Implant Direct Sybron Manufacturing, Westlake Village, CA
Classification: Class II
Status: Terminated
Recall initiated: 5 Jul 2016
FDA classified: 2 Aug 2016
Reported: 10 Aug 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

5 Jul 2016	Recall initiated by company
2 Aug 2016	Classified by FDA	+28 days
10 Aug 2016	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

Issue with design specification; oversized condition.

Product as listed by the FDA

RePlant¿ Angled Abutment Part Number 6050-52-60

Where it was distributed

U.S. distribution to the following; CA, WA, UT, GA, AZ, NE, OR, MI, TX, WI, FL, AL, AR, MO, VA, MA, TN, LA, NC, KS, NY, SC, OK. Foreign distribution to the following; CA, DE, IT, GB, PL, DE, GB, NL, GR, ES, HR, BG.

Alabama Arkansas Arizona California Delaware Florida Georgia Kansas Louisiana Massachusetts Michigan Missouri North Carolina Nebraska New York Oklahoma Oregon South Carolina Tennessee Texas

Questions about this recall

Why was it recalled?

Issue with design specification; oversized condition.

Which lots are affected?

Lot #50174, 39799, 49364

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.

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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