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U.S. Department of Health and Human Services

Class 2 Device Recall Mini Sterilizable Tray

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 Class 2 Device Recall Mini Sterilizable Traysee related information
Date Initiated by FirmMay 01, 2025
Date PostedJuly 25, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2172-2025
Recall Event ID 96778
510(K)NumberK200858 
Product Classification Sterilization wrap containers, trays, cassettes & other accessories - Product Code KCT
ProductThe 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.
Code Information Lot # 15006511/UDI: (10)841307125310
FEI Number 3001617766
Recalling Firm/
Manufacturer		 Implant Direct Sybron Manufacturing LLC
3050 E Hillcrest Dr
Westlake Village CA 91362-3171
For Additional Information ContactImplant Direct Customer Service
1888-649-6425
Manufacturer Reason
for Recall		The Drill stop kit contains incorrect components.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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.
Quantity in Commerce45 Kits
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KCT
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