PlainRecordsThe Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store…
- Reason
- The Drill stop kit contains incorrect components.
- Status
- 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.
- Enforcement report date
- Aug. 6, 2025
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- Implant Direct Sybron Manufacturing LLC
- Product
- 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
- The Drill stop kit contains incorrect components.
- 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.
- Quantity
- 45 Kits
- Codes and lots
- Lot # 15006511/UDI: (10)841307125310
- Recall started
- May 1, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- On May 2, 2025, Implant Direct issued a "Urgent: Medical Device Recall" Notification" letter to affected consignees via UPS or Email. Implant Direct ask consignees to take the following actions: 1. Please check your inventory immediately for any affected units and quarantine to ensure the product is not used. 2. PLEASE SHARE THIS NOTICE WITH THOSE WHO NEED TO BE AWARE WITHIN YOUR ORGANIZATION. 3. IMPLANT DIRECT KINDLY REQUESTS YOUR COOPERATION IN COMPLETING AND EMAILING BACK THE ENCLOSED ACKNOWLEDGEMENT FORM IN ORDER TO CONFIRM YOUR RECEIPT OF THIS URGENT MEDICAL DEVICE RECALL LETTER, REGARDLESS OF WHETHER YOU HAVE ANY PRODUCT IN YOUR INVENTORY.
- Recall number
- Z-2172-2025
What the record says about this device
A simplified drawing of a device, following the words of FDA's record. It shows the reason the record gives, not a photograph of the product.
“The Drill stop kit contains incorrect components.”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., FDA enforcement report, 2025-08-06. The caption is the record's own words.
A generic device, not the product. The mark follows the record's own words.
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FDA device name: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Distributed in (FDA's record): Alabama Florida Louisiana Maryland Nevada New Jersey New York Ohio Oklahoma Tennessee Texas Utah Virginia and nationwide
This recall among the others
- FDA's enforcement report came 97 days after the firm started the recall. For half of the 972 FDA medical device recall events reported in 2025 with a start date, it took 44 days or fewer (by year).
- Implant Direct Sybron Manufacturing: 1 other recall or notice on this site in the three years before this one (from Aug. 7, 2022).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement report, recall number Z-2172-2025. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-2172-2025, Aug. 6, 2025. "The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store." PlainRecords, https://plainrecords.com/recall/device/z-2172-2025/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections