—#171680

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.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K152170
Affected lot / code info: Serial Numbers: 5774515, 5774517, 5774518, 5774519, 5774520, 5774521, 5774525, 5774526, 5774527, 5774529, 5774531, 5774532, 5774533, 5774534, 5774535, 5774541, 5774543

Why it was recalled

2.5 Truliant Fit Trays were mismarked as 3

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

The firm initiated the recall by telephone and email on 03/13/2019. The letter explained the issue and requested that the consignee cease use and distribution of the product, notify anyone to whom the recalled product was distributed, and quarantine the product. The firm is seeking return of the recalled units.

Recalling firm

Firm: Exactech, Inc.
Address: 2320 NW 66th Ct, Gainesville, Florida 32653-1630

Distribution

Distribution pattern: US Nationwide Distribution in the states of AR, CA, OH, OK, IN, MN, NJ, TN, SC, FL

Timeline

Recall initiated: 2019-03-13
Terminated: 2021-04-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171680. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.