Z-0604-2018 Class II Terminated
FDA device recall Z-0604-2018 was initiated by Synthes (USA) Products LLC on July 21, 2017 and is designated Class II. Reason for recall: The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot. The recall status is terminated (terminated July 10, 2018). Affected quantity: 4 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 21, 2018
- Initiation Date
- July 21, 2017
- Termination Date
- July 10, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units
Product Description
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 Pattern
TX, GA, PA, UT and Canada
Code Information
Lot H302839, Expiration Date 31Jan2026