Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported August 6, 2025
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 osteotom
The Drill stop kit contains incorrect components.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Implant Direct Sybron Manufacturing LLC recalled The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, st… - a moderate-severity action.
The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, st… was recalled by Implant Direct Sybron Manufacturing LLC in August 6, 2025. Reason: The Drill stop kit contains incorrect components.. Check the official notice for the remedy. Verify recall #Z-2172-2025 with the FDA Devices before acting.
The recall
Implant Direct Sybron Manufacturing LLC issued this moderate-severity FDA Devices recall-The Drill stop kit contains incorrect components..
- Moderate
- severity level
- Class II
- classification
- August 6, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2172-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2172-2025) was formally reported on August 6, 2025, with the manufacturer initiating the action on May 1, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Implant Direct Sybron Manufacturing LLC is listed as the recalling firm, operating out of Westlake Village, CA. Federal records list the affected scope as 45 Kits.
The documented reason for this recall is: The Drill stop kit contains incorrect components. Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
45 Kits
Related Recalls
6
3 from same agency
Product description
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.
Reason for recall
The Drill stop kit contains incorrect components.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2172-2025 |
| Date reported | August 6, 2025 |
| Date initiated | May 1, 2025 |
| Recalling firm | Implant Direct Sybron Manufacturing LLC |
| Firm location | Westlake Village, CA |
| Affected scope | 45 Kits |
| 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2172-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Implant Direct Sybron Manufacturing LLC. Units affected: 45 Kits.
Why was this product recalled? ▼
The Drill stop kit contains incorrect components.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 6, 2025. Severity: Moderate. Recall number: Z-2172-2025.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2172-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 6, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.