Z-1749-2018 Class II Terminated
FDA device recall Z-1749-2018 was initiated by DePuy Mitek, Inc., a Johnson & Johnson Co. on December 22, 2017 and is designated Class II. Reason for recall: Reports of product loosening or coming unscrewed from the handle. The recall status is terminated (terminated July 16, 2019). Affected quantity: 84.
Recall Details
- Product Type
- Devices
- Report Date
- May 16, 2018
- Initiation Date
- December 22, 2017
- Termination Date
- July 16, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 84
Product Description
LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERIENCE Instability Shoulder Set is intended to provide to the orthopedic surgeon with a means of bone fixation and to assist in the management of reconstructive surgeries.
Reason for Recall
Reports of product loosening or coming unscrewed from the handle.
Distribution Pattern
US Nationwide Distribution in the states of OH, WA, CO
Code Information
16D01,16D02, 16K01, 17A01, 17B01, 17B02