CLASS II ONGOING Device recall · Reported 6 Aug 2025 · FDA Enforcement Report
The Drill Stop Kit recalled by Implant Direct Sybron
Implant Direct Sybron Manufacturing is recalling The Drill Stop Kit is the, distributed nationwide in the US. The recall was initiated on 1 May 2025 and the FDA has classified it as Class II.
Check your package
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-2172-2025
- FDA event ID
- 96778
- Recalling firm
- Implant Direct Sybron Manufacturing, Westlake Village, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 May 2025
- FDA classified
- 25 Jul 2025
- Reported
- 6 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 1 May 2025 | Recall initiated by company | |
| 25 Jul 2025 | Classified by FDA | +85 days |
| 6 Aug 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Drill stop kit contains incorrect components.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlabamaFloridaLouisianaMarylandNew JerseyNevadaNew YorkOhioOklahomaTennesseeTexasUtahVirginia
Questions about this recall
Why was it recalled?
The Drill stop kit contains incorrect components.
Which lots are affected?
Lot # 15006511/UDI: (10)841307125310
Where was it sold?
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.
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 |
|---|---|---|---|---|---|
| Device | CLASS II | Legacy Smartbase, Ne 3.0d 1mml recalled by Implant Direct Sybron | Implant Direct Sybron Manufacturing | Other | Nationwide |
| Device | CLASS II | ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD recalled | Implant Direct Sybron Manufacturing | Packaging Defects | Nationwide |
| Device | CLASS II | ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD recalled | Implant Direct Sybron Manufacturing | Packaging Defects | Nationwide |
| Device | CLASS II | SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform recalled | Implant Direct Sybron Manufacturing | Device Malfunction | CA |
| Device | CLASS II | Implant Direct, CE recalled | Implant Direct Sybron Manufacturing | Packaging Defects | 22 states |
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