PlainRecalls
FDA Devices Moderate Class II Terminated

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 rheumat

Reported: November 1, 2017 Initiated: September 18, 2017 #Z-0043-2018

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.

Details

Units Affected
48 units
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
Location
Arlington, TN

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by MicroPort Orthopedics Inc.. Units affected: 48 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 1, 2017. Severity: Moderate. Recall number: Z-0043-2018.

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