FDA-Device2022-10-12Class II
Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
Synthes (USA) Products LLC
Hazard
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
Sold states
US Nationwide distribution.
Affected count
191 units
Manufactured in
1301 Goshen Pkwy, N/A, West Chester, PA, United States
Products
Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0008-2023Don't want to check this manually?
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