Reported Nov 1, 2017 · Terminated
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems…
MicroPort Orthopedics Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MicroPort Orthopedics Inc. · 5677 Airline Rd · Arlington, TN · 38002-9501
Is this the product you have?
4 of 4 products
| # | Product as published |
|---|---|
| 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 |
- Lot codes and dates
- lot 1723305
- Amount recalled
- 48 units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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