Total Toe Instrument Kit recall
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…
Why was Total Toe Instrument Kit recalled?
An oversight in the implementation of the design change record resulted in outdated components being shipped to customers. The component did not pass a half-cycle sterilization.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
SN 000242 SN 000244 SN 000246 SN 000247
- 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…
- Recalling firm
- Arthrosurface, Inc.
- Quantity
- 3 units
- Distribution
- US Distribution to the states of : PA, WV and CA.
- Recall date
- December 30, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)