Reported Jun 12, 2019 · Ongoing
Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone…
I.T.S. GmbH
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: I.T.S. GmbH · Autal 28 · Lasnitzhohe · N/A
Is this the product you have?
- Rim Plate, 10-Hole, Left, PRS RX System. Titanium
- implantable - Product UsageThe implant temporarily stabilizes bone segments until bony consolidation has taken place. After this, the implant has no more use and can be removed
- Lot codes and dates
- Model Number21206-10
- Lot Code26/F42778
- Amount recalled
- 65 devices
Where it was sold
Why it was recalled
The titanium implant has the wrong article number laser marked on it.
This product could cause temporary or reversible health problems — stop using it.
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