Reported Mar 18, 2020 · Terminated
Iliac Screws, multiple sizes, Article Nos. B36020500 B36020570 B36020580 B36020590 B36027500 B36027570 B36027580…
Medicrea International
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: Medicrea International · 5389 Route De Strasbourg · Rillieux La Pape · N/A
Is this the product you have?
- Iliac Screws, multiple sizes, Article Nos.Screws manufactured in titanium alloy Ti-6Al-4V LI conforming to ISO5832-3 and ASTM. F136 specifications. These screws are part of an internal fixation system composed of hooks, rods, plates, cross links, connection and locking devices.
B36020500B36020570B36020580B36020590B36027500B36027570B36027580B36027590B36028500B36028570B36028580B36028590B36029500B36029570B36029580B36029590
- Lot codes and dates
- Lots
19D068319D068419D068519D068619D036919H047019D037019H047319D037119G107119L050119D037219G107319D057019G107519J044519D057119G107619J086719D057219G052119J086819L052619L050219L052519D057319G052219J086919D057419G107719L050319D057519H047419D057619G052319G107819D057719G107919H0475
- Lots
- Amount recalled
- 3529
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or after screw insertion, or during the reduction step.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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