Implant Direct Sybron Manufacturing LLC recall records

2 reported ongoing

2 records in this archive. Latest source date May 1, 2025.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitate the mounting/removal of the Drill Stop...

The Drill stop kit contains incorrect components.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of AL, FL, LA, MD, NJ, NV, NY, OH, OK, TN, TX, UT, VA and the country of Japan.

Official source for The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize,...
FDA device enforcement

LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW NE 3.5D, REF: 8735-80NNE; LEGACY SMARTBASE, NE 3.5D 2MML, ...

Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of FL, ID, TX, CA.

Official source for LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LE...

Reasons in these listed records

  • The Drill stop kit contains incorrect components.
  • Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.

These examples come from this result page and are not a ranking of every recall reason.

Checking Implant Direct Sybron Manufacturing LLC

Is there a recall on implant direct sybron manufacturing llc right now?

This archive contains 2 records, including 2 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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