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Recall Observatory FDA recall evidence

Device product

Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001

Z-0008-2023

August 30, 2022

Class II

Product summary

Firm
Synthes (USA) Products LLC
Event
Event 90842
Status
Ongoing
Classification
Class II
Quantity
191 units
Official record key
device-enforcement:Z-0008-2023

Official wording

Reason: 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

Code information: UDI-DI: 00810633022047 Lot Numbers: MHC220119, MHC220120 Expiry Date: 1 June 2027

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    packaging error