Recall Z-1749-2018— DePuy Mitek, Inc., a Johnson & Johnson Co.
Class II · Terminated
Class II FDA medical device recall by DePuy Mitek, Inc., a Johnson & Johnson Co., initiated 2017-12-22, terminated 2019-07-16. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-12-22
- Terminated
- 2019-07-16
- Firm location
- Raynham, MA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.