MicroPort Orthopedics Inc.

Entity profile compiled from public source records

Public Record Profile Registrations: 2 510(k) filings: 0 Recalls: 1

Known Identifiers & Locations

FEI Numbers 3010536692, 3010856250
Owner Operator Numbers 10045253
Locations Covered Arlington, TN, US; Sabana Norte San Jose, CR

Registered Establishments (2)

Registration # Establishment Name Location Establishment Type(s) Action
3010536692 MICROPORT ORTHOPEDICS INC. Arlington, TN, US Manufacture Medical Device View Details
3010856250 Microport Orthopedics, S.A. Sabana Norte San Jose, CR Develop Specifications But Do Not Manufacture At This Facility View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (1)

Recall # Product Description Initiation Date Status Action
Z-0043-2018 MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed Reason: The item is being recalled due to an inadequate pouch seal. This defect has the potential to lead to a loss of sterile pouch integrity, which could impact the products sterility assurance and may lead to serious adverse events such as infections, both localized and systemic. 2017-09-18 Terminated View Details

Profile Disclaimer

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