medical Class II Updated 2019-05-01

Exactech, Inc. recalls Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number

Recalled Product

Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 Product Usage: Knee 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.

Hazard / Issue

2.5 Truliant Fit Trays were mismarked as 3

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: 5774515, 5774517, 5774518, 5774519, 5774520, 5774521, 5774525, 5774526, 5774527, 5774529, 5774531, 5774532, 5774533, 5774534, 5774535, 5774541, 5774543
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