MicroPort Orthopedics SCHANZ SCREW SELF DRILL — Class II medical device recall Z-0043-2018
Terminated recall by MicroPort Orthopedics Inc., reported 2017-11-01, distributed nationwide. The item is being recalled due to an inadequate pouch seal. This defect has the potential to lead to a loss of
| Recall number | Z-0043-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MicroPort Orthopedics Inc., Arlington, TN, United States |
| Recall initiated | 2017-09-18 |
| Classified | 2017-10-20 |
| Reported by FDA | 2017-11-01 |
| Terminated | 2021-04-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 48 units |
| Reason classes | sterility, packaging |
| Lot numbers | 1723305 |
| Model numbers | 20070057 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0043-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.