FDA Recall
Terminated
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.
Recall: Z-1749-2018
·
Initiated December 22, 2017
Recall
- Recall Number
- Z-1749-2018
- Event Number
- 79518
- Firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- FEI Number
- 1221934
- Product Code
- LXH
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- December 22, 2017
- Terminated
- July 16, 2019
- Address
- 325 Paramount Dr, Raynham, MA, 02767-5199
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
Reports of product loosening or coming unscrewed from the handle.
Action
In January of 2018 an URGENT MEDICAL DEVICE RECALL letter was issued to customers requesting all to cease further distribution or use of the product which should be quarantined and returned to the firm. If the product was further distributed it is requested that those customers follow recall procedures. Questions or concerns can be directed to 508-828-3647.
Distribution
US Nationwide Distribution in the states of OH, WA, CO
Quantity
84