[pending] Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
Pending LLM rewrite. Source: FDA_DEVICE Z-0008-2023.
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: Pending LLM scoring against the rubric.
Plain-English summary
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
The recalled product
- Product
- Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
- Manufacturer
- Synthes (USA) Products LLC
- Category
- Medical Device — Devices
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)
- UDI-DI: 00810633022047 Lot Numbers: MHC220119
- MHC220120 Expiry Date: 1 June 2027
Distribution
Distributed nationwide across the United States.
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