FDA Enforcement
Class II
Terminated
11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile
Recall: Z-0604-2018
·
Reported February 21, 2018
Enforcement
- Recall Number
- Z-0604-2018
- Event ID
- 78958
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Synthes (USA) Products LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 21, 2018
- Initiation Date
- July 21, 2017
- Classification Date
- February 13, 2018
- Termination Date
- July 10, 2018
- Address
- 1301 Goshen Pkwy, West Chester, PA, 19380-5986, United States
Description
11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile
Reason
The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot.
Code Info
Lot H302839, Expiration Date 31Jan2026
Distribution
TX, GA, PA, UT and Canada
Quantity
4 units