Z-0043-2018 Class II Terminated
FDA device recall Z-0043-2018 was initiated by MicroPort Orthopedics Inc. on September 18, 2017 and is designated Class II. 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 lea… The recall status is terminated (terminated April 8, 2021). Affected quantity: 48 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 1, 2017
- Initiation Date
- September 18, 2017
- Termination Date
- April 8, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48 units
Product Description
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 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 Pattern
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
Code Information
lot 1723305