Hammertoe Continuous Compression Implant recall
Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
Why was Hammertoe Continuous Compression Implant recalled?
Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error, result in a surgical delay and may cause soft tissue damage if a larger incision is required to accommodate an alternative form of fixation. Additionally, there is a potential for adverse tissue reaction if the surgeon attempts to use the guide regardless of tight fit and plastic debris is created and ends up in the wound
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
UDI-DI: 00810633022047 Lot Numbers: MHC220119, MHC220120 Expiry Date: 1 June 2027
- Product
- Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
- Recalling firm
- Synthes (USA) Products LLC
- Quantity
- 191 units
- Distribution
- US Nationwide distribution.
- Recall date
- October 12, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)