Recall Z-2172-2025 ยท KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Implant Direct Sybron Manufacturing LLC
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
| Date | Jul 25, 2025 (initiated May 1, 2025) |
| Status | Open, Classified |
| Reason | The Drill stop kit contains incorrect components. |
| Root cause | Under Investigation by firm |
| Action | 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, REG |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200858 | Mini Sterilizable Tray Implant Direct Sybron Manufacturing, LLC, Aug 6, 2020 |