Arthrex Recalls Cannulated Drill Bits Due to Incorrect Color Indicator
Arthrex, Inc. is recalling 9 units of 5.0 mm cannulated drill bits because the color indicator on the shaft is the incorrect color.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a cosmetic defect (incorrect color indicator) with no reported injuries or illnesses, fitting the criteria for a Low severity recall.
Plain-English summary
Arthrex, Inc. is recalling 9 units of the Drill Bit, Cannulated, 5.0 mm (Product Code AR-8770-02, Lot Number 032052). The recall is due to the color indicator on the proximal end of the shaft being the incorrect color.
The affected products were distributed nationwide in the United States, specifically in the states of Ohio, Oregon, Tennessee, and Texas. These drill bits may be used in a variety of foot and ankle procedures.
The source text does not specify instructions for consumers or healthcare providers regarding the disposition of the recalled units.
The recalled product
- Product
- Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.
- Manufacturer
- Arthrex, Inc.
- Hazard
- Affected units
- 9
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)
- Product Code AR-8770-02
- Lot Number 032052
Distribution
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