Z-1514-2018 Class II Terminated
FDA device recall Z-1514-2018 was initiated by Synthes, Inc. on March 19, 2018 and is designated Class II. Reason for recall: There is a potential for the connection screw of the stem extractor to break. The recall status is terminated (terminated April 11, 2019). Affected quantity: 31.
Recall Details
- Product Type
- Devices
- Report Date
- May 2, 2018
- Initiation Date
- March 19, 2018
- Termination Date
- April 11, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31
Product Description
Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.
Reason for Recall
There is a potential for the connection screw of the stem extractor to break.
Distribution Pattern
Worldwide Distribution: US (nationwide) and to countries of: Canada and Switzerland.
Code Information
09-6793, 10-2637, 10-5070, 12-2707, 14-1085, 15-8949