Drill Stop Kit - Long CDSKLRecalls & reported problems
Implant Direct Sybron Manufacturing LLC · Drill Stops (Qty 24) Tray & Pan (Qty 1) Bracket Set (Qty 1) · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841307125303), received between Apr 26, 2023 and Apr 26, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Corroded” (1 report).
1 other recall cover devices cleared under the same FDA submission (K200858); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Corroded1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 26, 2023Corroded; Corroded
PER COMPLAINT 203262663, BEFORE CLINICAL PROCEDURE, SURFACE DEFECT WAS OBSERVED.
Patient problems: Failure of Implant
MAUDE report 16815369 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K200858. One submission often covers many models, so check the product and lot details in each record.
- Z-2172-2025 · May 1, 2025 · Open, ClassifiedThe 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.
Other Sterilization Wrap Containers, Trays, Cassettes & Other Accessories devices
- None 400498Intuitive Surgical, Inc. · Sterilization wrap containers, trays, cassettes & other accessories1 recall2 reports
- V. Mueller CD4-3STCarefusion 2200, Inc · Sterilization wrap containers, trays, cassettes & other accessories1 recall0 reports
- V. Mueller CD5-61B-PURPLECarefusion 2200, Inc · Sterilization wrap containers, trays, cassettes & other accessories1 recall0 reports
- V. Mueller CD3-4STCarefusion 2200, Inc · Sterilization wrap containers, trays, cassettes & other accessories1 recall0 reports
- AESCULAP US751Aesculap, Inc. · Sterilization wrap containers, trays, cassettes & other accessories50 reports
- V. Mueller CD5-3B-REDCarefusion 2200, Inc · Sterilization wrap containers, trays, cassettes & other accessories1 recall0 reports
- V. Mueller CD5-3STCarefusion 2200, Inc · Sterilization wrap containers, trays, cassettes & other accessories1 recall0 reports
- V. Mueller CD5-3C-PURPLECarefusion 2200, Inc · Sterilization wrap containers, trays, cassettes & other accessories1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.