Z-1749-2018Class II

LATARJET EXPERIENCE Sharp Curved Ostetome

Name: Z-1749-2018 LATARJET EXPERIENCE Sharp Curved Ostetome
Creator: DePuy Mitek, Inc., a Johnson & Johnson Co.
Published: 2017-12-22
License: https://open.fda.gov/license/

DePuy Mitek, Inc. / initiated 2017-12-22 / Terminated / root cause: manufacturing process

FDA source

DePuy Mitek, Inc., a Johnson & Johnson Co. began a recall of LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERIENCE Instability Shoulder Set is intended to provide to the orthopedic surgeon with... on 2017-12-22. FDA classified it as Class II and gives the reason as "Reports of product loosening or coming unscrewed from the handle". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1749-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-22
Posted: 2018-05-08
Terminated: 2019-07-16
Recalling firm: DePuy Mitek, Inc.
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.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Reports of product loosening or coming unscrewed from the handle.
Root cause tag: manufacturing process
FDA 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 in commerce: 84
Distribution: US Nationwide Distribution in the states of OH, WA, CO
Product codes and lots: 16D01,16D02, 16K01, 17A01, 17B01, 17B02

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1749-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1749-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-08

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)