Dental Drill Stop Kit Recalled for Incorrect Components
Implant Direct Sybron Manufacturing LLC recalls 45 Drill Stop Kits due to incorrect components. The kits are used in dental implant procedures and were distributed in 14 US states and Japan.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall with no reported injuries or illnesses. The incorrect components pose a risk of affecting proper function in dental implant procedures, meeting the criterion for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The Drill Stop Kit, manufactured by Implant Direct Sybron Manufacturing LLC, is being recalled. This product is a specialized sterilizable tray used to store, sterilize, verify the length of Drill Stops, and facilitate their mounting and removal during dental implant procedures. The kit includes a Release Bracket and optionally stores DLC drills.
The recalled kits contain incorrect components, which may affect their ability to function properly during dental implant procedures.
The recall affects 45 kits with lot number 15006511 (UDI: (10)841307125310) that were distributed worldwide in Alabama, Florida, Louisiana, Maryland, New Jersey, Nevada, New York, Ohio, Oklahoma, Tennessee, Texas, Utah, Virginia, and Japan.
Practitioners and healthcare facilities should contact Implant Direct Sybron Manufacturing LLC for instructions regarding this recall. Any affected kits should be withdrawn from use until replacement components or kits are provided.
The recalled product
- 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
- Manufacturer
- Implant Direct Sybron Manufacturing LLC
- Hazard
- incorrect-components
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 15006511/UDI: (10)841307125310
Distribution
Distributed nationwide across the United States.
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