Reported Mar 18, 2020 · Terminated
Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B36004540 B36004545 B36004550 B36004555…
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?
- Pedicle 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.
B36004525B36004530B36004535B36004540B36004545B36004550B36004555B36005530B36005535B36005540B36005545B36005550B36005555B36005560B36006530B36006535B36006540B36006545B36006550B36006555B36006560B36007535B36007540B36007545B36007550B36007555B36007560B36008535B36008540B36008545B36008550B36008555B36008560B36009535B36009540B36009545B36009550B36009555B36009560
- Lot codes and dates
- Lots
140 of 140 codes
19C064419J100819C064519J100919C064619G106319J101019C064719G106519J101119C064819J101219C064919J101319C065019J101419C026919C0269R19H045819C027019C0270R19H045919J044019L047119C027119C0271R19D021919H046019J044119L020519L047219C027219D022019C0272R19H046319J044219L020619C027319D022119C0273R19H046419J044319C027419C0274R19D022219C027519C0275R19H046719B084719B0847R19L020919L047319B084819D022319B0848R19F022619L021419B084919D022419B0849R
- 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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