Reported May 1, 2019 · Terminated
Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 Product Usage: Knee joint…
Exactech, 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: Exactech, Inc. · 2320 NW 66th Ct · Gainesville, FL · 32653-1630
Is this the product you have?
- Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog
- Number 02-022-45-3030 Product UsageKnee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented The OPTETRAK Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems
- Lot codes and dates
- Serial Numbers
57745155774517577451857745195774520577452157745255774526577452757745295774531577453257745335774534577453557745415774543
- Serial Numbers
- Amount recalled
- 18 units
Where it was sold
Why it was recalled
2.5 Truliant Fit Trays were mismarked as 3
This product could cause temporary or reversible health problems — stop using it.
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