Arthrosurface Total Toe Instrument Kit Recalled for Sterilization Failure
Arthrosurface is recalling 3 Total Toe Instrument Kits because a hex driver component failed to pass half-cycle sterilization due to a design oversight.
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: The recall is classified as FDA Class II, and the hazard involves a medical device component that failed sterilization, posing a risk of harm where injury has not yet been reported.
Plain-English summary
Arthrosurface, Inc. is recalling 3 units of the Total Toe Instrument Kit, labeled in part as "Instrument Set, 15mm Toe, Dorsal Flange Combi" (Part Number 9000-3002). The specific component involved in this recall is the hex driver (Part Number 2009-4001). The affected serial numbers are 000242, 000244, 000246, and 000247.
The recall was initiated because an oversight in the implementation of a design change record resulted in outdated components being shipped to customers. Specifically, the hex driver component did not pass a half-cycle sterilization process. This is classified as an FDA Class II recall.
The affected units were distributed in the United States to the states of Pennsylvania (PA), West Virginia (WV), and California (CA). Consumers and healthcare providers who possess these specific serial numbers should stop using the affected hex driver components and contact Arthrosurface, Inc. for further instructions or replacement.
The recalled product
- Product
- Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002 The component in question is the hex driver (part number 2009-4001).
- Manufacturer
- Arthrosurface, Inc.
- Affected units
- 3
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)
- SN 000242 SN 000244 SN 000246 SN 000247
Distribution
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