CLASS II Device recall · Reported 14 Feb 2018 · FDA Enforcement Report

Implant Direct, Interactive Healing Collar recalled

Implant Direct Sybron Manufacturing is recalling Implant Direct, Interactive Healing Collar, distributed in 8 states. The recall was initiated on 23 Jan 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number 104203

Quantity recalled55 units

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-0539-2018
FDA event ID: 78917
Recalling firm: Implant Direct Sybron Manufacturing, Westlake Village, CA
Classification: Class II
Status: Terminated
Recall initiated: 23 Jan 2018
FDA classified: 6 Feb 2018
Reported: 14 Feb 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

23 Jan 2018	Recall initiated by company
6 Feb 2018	Classified by FDA	+14 days
14 Feb 2018	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

InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being sterilized.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform

Where it was distributed

CO, SC, IA, NJ, FL, CA, VA, ID, Netherlands

California Colorado Florida Iowa Idaho New Jersey South Carolina Virginia

Questions about this recall

Why was it recalled?

InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being sterilized.

Which lots are affected?

Lot Number 104203

Where was it sold?

CO, SC, IA, NJ, FL, CA, VA, ID, 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 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

Other Other Medical Devices recalls

All 13,908

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Plastics Tray kits recalled by Avid Medical	Avid Medical	Foreign Material	Nationwide
14 Oct 2026Device	CLASS II	Heart Prep Tray kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Pack Open Heart Cfh kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Sperm Ab Elisa (96 well plate test) recalled by DRG International	DRG International	Other	Nationwide
14 Oct 2026Device	CLASS III	BeneView Series recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide