Reported Oct 12, 2022 · Ongoing
Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
Synthes (USA) Products LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Synthes (USA) Products LLC · 1301 Goshen Pkwy · West Chester, PA · 19380-5986
Is this the product you have?
- Hammertoe Continuous Compression
- Implant (CCI) Kit Part Number46.239.001
- Lot codes and dates
- UDI-DI00810633022047
- Lot NumbersMHC220119
- MHC220120 Expiry Date1 June 2027
- Amount recalled
- 191 units
Where it was sold
- Nationwide
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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