ConMed Linvatec Recalls Sentinel Cannulated Drill Bits Due to Labeling Errors
ConMed Linvatec is recalling specific lots of Sentinel Cannulated Drill Bits because of incorrect labeling on the packages.
What this means for you
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: The recall is classified as FDA Class II and is due to a labeling error. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported harm are rated as Moderate.
Plain-English summary
Linvatec Corporation dba ConMed Linvatec is recalling the S8580, 8.0MM Sentinel Cannulated Drill Bit (lot numbers 322225 and 322226) and the S8585, 8.5MM Sentinel Cannulated Drill Bit (lot number 322287). These medical devices are used for drilling bone tunnels in ACL and PCL reconstruction.
The recall was initiated due to incorrect labeling on the packages. The source text does not specify the nature of the labeling error or report any illnesses or injuries associated with the use of these devices.
The affected products were distributed worldwide, including in the United States (NJ, UT, GA, NY, PA, IL, LA, OH, CA, MS) and internationally to Canada, Japan, and Romania. Healthcare providers should verify their inventory against the specific lot numbers listed and stop using the affected units.
The recalled product
- Product
- "***SENTINEL***Cannulated Drill Bit***S8580***8 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2012-03***". This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction.
- Manufacturer
- Linvatec Corp. dba ConMed Linvatec
- Hazard
- Affected units
- 70
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 (2)
- S8580 (8.0MM Drill Bit)
- lot numbers 322225 and 322226
Distribution
Part of a larger recall action
This product is one of 2 recalled by Linvatec Corp. dba ConMed Linvatec under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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