MicroPort Orthopedics SCHANZ Screws: Risk of Infection from Sterile Pouch Defect
MicroPort Orthopedics recalls SCHANZ SCREWS with defective sterile pouch seals that could cause infections during hip surgery. Affected units include specific model and lot numbers for total hip replacements.
Use caution until it’s fixed
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 product s sterility assurance and may lead to serious adverse events such as infections, both localized and systemic.
Contact the company
What happened, in plain English
MicroPort Orthopedics is recalling SCHANZ SCREWS used in total hip replacements due to a pouch seal defect that might compromise sterility and cause infections. This is serious because surgical infections can lead to complications like sepsis or prolonged recovery. Read more at govinfonow.com/recall/73010-microport-orthopedics-schanz-screws-risk-of-infection-from-sterile-pouch.
Source Summary by GovInfoNow · govinfonow.com/recall/73010-microport-orthopedics-schanz-screws-risk-of-infection-from-sterile-pouch · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0043-2018
Cite this page
“MicroPort Orthopedics SCHANZ Screws: Risk of Infection from Sterile Pouch Defect.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/73010-microport-orthopedics-schanz-screws-risk-of-infection-from-sterile-pouch. Based on FDA recall #Z-0043-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0043-2018%22&limit=1).
Why it’s dangerous
The sterile pouch seal is inadequate, which could allow contamination. This might lead to infections at the surgical site, potentially causing serious complications like sepsis or systemic infections.
Who’s affected
Patients who received total hip replacements using this specific screw model and lot number are affected. Surgeons and medical staff using the product during procedures may also be at risk.
How to tell if you have this one
Check for the product name 'SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057' and lot number 1723305 on the sterile pouch. This product is used in MicroPort Total Hip Systems.
- Brand
MicroPort Orthopedics- Category
Medical device
What to do — step by step
Check Product Details
Look for the model number 20070057 and lot number 1723305 on the sterile pouch.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 10 states.
FDA 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” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Colorado, Kansas, Louisiana, Maine, Maryland, Missouri, Puerto Rico, Texas.
Recall timeline
FDA terminated this recall 3.6 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0043-2018 (September 18, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0043-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.