Food, drugs, devices › DePuy Mitek, Inc., a Johnson & Johnson Co.
Device recall: LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERIENCE Instability Shoulder Set is intended to
FDA enforcement event 79518 is a device recall by DePuy Mitek, Inc., a Johnson & Johnson Co. of Raynham, MA, initiated 22 Dec 2017 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 16 Jul 2019. Initiation: voluntary: firm initiated. DePuy Mitek, Inc., a Johnson & Johnson Co. has 16 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
DePuy Mitek, Inc., a Johnson & Johnson Co., Raynham, MA.
Reason for recall
"Reports of product loosening or coming unscrewed from the handle."
Distribution
"US Nationwide Distribution in the states of OH, WA, CO"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1749-2018 | 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. | 84 | Class II | Terminated | 16 May 2018 |
Context
Other enforcement events for DePuy Mitek, Inc., a Johnson & Johnson Co.
All 16 events for DePuy Mitek, Inc., a Johnson & Johnson Co.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Reports of product loosening or coming unscrewed from the handle."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide Distribution in the states of OH, WA, CO"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 16 Jul 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.