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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96778

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
May 01, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Implant Direct Sybron Manufacturing LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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 Stops. The Drill Stop Kit includes the Release Bracket, which is used for mounting and removing Drill Stops, as well as verifying the length of the Drill Stops via a ruler and depth markings. The Drill Stop Kit also allows for optional storage of some DLC drills. Drill Stops: The Drill Stop is a reusable (up to 30 osteotomies) hollow cylinder with retention prongs that clips onto the hub of the DLC drill, creating a stop function at the desired predetermined drill depth (6mm, 8mm, 10mm, 11.5mm, 13mm and 16mm). The Drill Stops come in two formats (Short  6-13mm depth, and Long  6-16mm depth), and in several diameters for different diameter drills.

Z-2172-2025
Recall number
Z-2172-2025
Initiated
May 01, 2025
Classification
Class II
Status
Ongoing
Quantity
45 Kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Drill stop kit contains incorrect components.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Drill stop kit contains incorrect components.

Code information

Lot # 15006511/UDI: (10)841307125310

Distribution pattern

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.