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
- Company
- Microport Orthopedics Inc.
- Recall Initiated
- September 18, 2017
- Terminated
- April 8, 2021
- Recall Number
- Z-0043-2018
- Quantity
- 48 units
- Firm Location
- Arlington, TN
Reason for Recall
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.
Distribution
Worldwide Distribution - US Nationwide in the states of TX, AL, AZ CO, KS ,ME MO, WB, LA, CA, MD, including PR and the country of CANADA
Lot / Code Info
lot 1723305
Root Cause
Packaging process control
Action Taken
Microport initiated their recall by letter sent via email on 09/18/2017. The letter identified the affected product, problem and actions to be taken. The consignees were directed to check their stock, including all kits and consignment stock to immediately determine if any affected product was in stock. The firm requested return of the recalled units. Consignees with questions regarding the return of the product were directed MPOs Customer Experience Department available Monday through Friday 7:30 am to 7:30 pm CST, at 1-866-872-0211.