Reported Dec 18, 2019 · Terminated
P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182,…
Paragon 28, Inc.
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: Paragon 28, Inc. · 4B Inverness Ct E Ste 280 · Englewood, CO · 80112-5329
Is this the product you have?
- P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S
- TypeLagrge
- Size10mm, (01) 00889795018182, Sterile R, Single Use Only
- Lot codes and dates
- Lot # BR4108
- Amount recalled
- 64 Wedge Systems
Where it was sold
Why it was recalled
It has been determined that the wedge implant kit is permanently mislabeled with the wrong size. The wedge implant is a 10mm size and is permanently marked as a 12mm size. Use of the product could result in improper preparation of the surgical site causing delays in surgery.
This product could cause temporary or reversible health problems — stop using it.
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