Sterilizable Drill Stop Kits were shipped containing incorrect components
The Drill Stop Kit, a version of the Mini Sterilizable Tray used to store, sterilize and verify drill stop length, is being recalled because it contains incorrect components. 45 kits affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall for a kit assembled with the wrong components, with no clinical consequence stated in the source.
Plain-English summary
The Drill Stop Kit, the version of the Mini Sterilizable Tray used to store, sterilize and verify drill stop length and to facilitate mounting and removal of the drill stops, including the release bracket, is being recalled. The action covers 45 kits from lot 15006511, UDI 841307125310.
The stated reason is that the drill stop kit contains incorrect components. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.
Distribution was worldwide, including nationwide in the United States across Alabama, Florida, Louisiana, Maryland, New Jersey and Nevada among other states. The kits are supplied to surgical facilities rather than sold to consumers.
Facilities should identify affected stock using the lot number and UDI above and follow the instructions issued by the manufacturer.
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…
- Manufacturer
- Implant Direct Sybron Manufacturing LLC
- Affected units
- 45
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
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