Implant Direct Sybron Manufacturing recalls

Implant Direct Sybron Manufacturing has 33 recalls on record with the FDA and USDA, the earliest in 2015 and the latest reported on 6 Aug 2025. 4 are still ongoing. The most frequent reason is sterility.

Total recalls33since 2015

Last 12 months0reported

Class I00% of total

Ongoing4latest 6 Aug 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 1 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 33 100%Class III 0 0%

Why implant direct sybron manufacturing is recalled

Product types

By year

202513%
202313%
202126%
2020515%
2019515%
2018824%
2017721%
201639%
201513%

Ongoing implant direct sybron manufacturing recalls

4 active

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

All implant direct sybron manufacturing recalls, newest first

33 total

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
19 Feb 2020Device	CLASS II	Implant Direct, CE recalled	Implant Direct Sybron Manufacturing	Sterility	22 states
12 Feb 2020Device	CLASS II	Legacy 3 Implant, Size: 2mmD x 13mmL, 5mmD Platform recalled	Implant Direct Sybron Manufacturing	Lead & Heavy Metals	Nationwide
15 Jan 2020Device	CLASS II	ImplantDirect InterActive Precision IO Scan Adapter recalled	Implant Direct Sybron Manufacturing	Sterility	26 states
15 Jan 2020Device	CLASS II	ImplantDirect InterActive Precision IO Scan Adapter recalled	Implant Direct Sybron Manufacturing	Sterility	26 states
20 Nov 2019Device	CLASS II	Implant Direct recalled	Implant Direct Sybron Manufacturing	Sterility	5 states

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.