FDA recall Z-0008-2023

Synthes (USA) Products LLC · Class II · device

Product

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

Reason for recall

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

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2022-08-30
Report date
2022-10-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
West Chester, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0008-2023