# FDA recall Z-0043-2018

> **MicroPort Orthopedics Inc.** · Class II · device recall initiated 2017-09-18.

## Product

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

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

## Key facts

- **Recall number:** Z-0043-2018
- **Recalling firm:** MicroPort Orthopedics Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-18
- **Report date:** 2017-11-01
- **Termination date:** 2021-04-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Arlington, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0043-2018

## Citation

> AI Analytics. FDA recall Z-0043-2018. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-0043-2018. Source: US FDA. Licensed CC0.

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