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.
This recall has been terminated (originally issued December 22, 2017).
- Recall Initiated
- December 22, 2017
- Terminated
- July 16, 2019
- Recall Number
- Z-1749-2018
- Quantity
- 84
- Firm Location
- Raynham, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Reports of product loosening or coming unscrewed from the handle.
Distribution
US Nationwide Distribution in the states of OH, WA, CO
Lot / Code Info
16D01,16D02, 16K01, 17A01, 17B01, 17B02
Root Cause
Process control
Action Taken
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.
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