FDA recall Z-0604-2018

Synthes (USA) Products LLC · Class II · device

Product

11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile

Reason for recall

The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot.

Distribution

TX, GA, PA, UT and Canada

Key facts

Status
Terminated
Initiation date
2017-07-21
Report date
2018-02-21
Termination date
2018-07-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
West Chester, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0604-2018