FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1749-2018
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- 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.
- Status
- Terminated
- Initiated
- 2017-12-22
- Posted
- not on file
- Terminated
- 2019-07-16
- 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
- Lot, serial or model codes
- 16D01,16D02, 16K01, 17A01, 17B01, 17B02
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 1221934
- Firm city
- Raynham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28