Djo Surgical
Country not established
- Devices
- 2
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Djo Surgical makes
Djo Surgical manufactures orthopedic implants, including reverse shoulder prostheses and the Keramos ceramic/ceramic total hip system. These devices are designed for joint replacement surgeries to restore function and mobility in shoulder and hip joints.
The company’s products are regulated under FDA pathways, with reverse shoulder prostheses classified as Class II and the Keramos hip system as Class III. They are listed under 510(k) and PMA submissions, reflecting their respective regulatory requirements. The manufacturer is based in the United States.
Catalogue
Reverse Shoulder Prosthesis Ref K092873
510(k) 510(k)Keramos Ceramic/Ceramic Total Hip System Ref N980003
PMA, withdrawn PMA
FDA recalls
FDA recall records list 1 recall initiated by Djo Surgical, initiated on 2014-02-07. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2014
- 7 Feb 2014 Z-1130-2014 Class II Terminated Packaging error -- two different types and sizes of acetabular liners used during hip replacement surgery were mistakenly packaged into each other's outer boxes after sterilization, resulting in the products being mislabeled. The units labeled as Model/Catalog Number 931-28-248 Lot/Serial Number 685F1034 on the outside and containing Model/Catalog Number 932-36-252, Lot# 728F1089 on the inside (1
Frequently asked questions
How many devices does Djo Surgical have in the registry?
The registry currently lists 2 devices for Djo Surgical. Devices recorded under merged duplicate company entries are counted once.
Which registries list Djo Surgical's devices?
Among its 2 most recently registered devices, Djo Surgical has devices listed in FDA 510(k) (1 device) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Djo Surgical's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Djo Surgical's devices are Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Djo Surgical?
FDA recall records list 1 recall initiated by Djo Surgical, the most recent initiated on 2014-02-07. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Djo Surgical in the registry?
The most recently registered devices listed for Djo Surgical include REVERSE SHOULDER PROSTHESIS and KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM.