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