The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop leng
FDA device recall Z-2172-2025 · posted 2025-07-25 · Open, Classified
Recall details
- Recalling firm
- Implant Direct Sybron Manufacturing LLC
- Reason for recall
- The Drill stop kit contains incorrect components.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- KCT
- Quantity affected
- 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.
- Date initiated
- 2025-05-01
- Date posted
- 2025-07-25
- Location
- Westlake Village, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Mini Sterilizable Tray (K200858) | Implant Direct Sybron Manufacturing, LLC | 2020-08-06 |