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Terminated

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 Recall Z-1208-2019 · Posted None

Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2019-03-13
Date Terminated2021-04-22
Product Quantity18 units

Reason for Recall

2.5 Truliant Fit Trays were mismarked as 3

Firm Action

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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