Recall Z-1749-2018 ยท LXH Orthopedic Manual Surgical Instrument
DePuy Mitek, Inc., a Johnson & Johnson Co.
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.
| Date | Dec 22, 2017 |
| Status | Terminated |
| Reason | Reports of product loosening or coming unscrewed from the handle. |
| Root cause | Process control |
| 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. |
| Quantity | 84 |
| Distribution | US Nationwide Distribution in the states of OH, WA, CO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.