Z-1208-2019Class II

Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030

Name: Z-1208-2019 Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030
Creator: Exactech, Inc.
Published: 2019-03-13
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2019-03-13 / Terminated

FDA source

Exactech, Inc. began a recall of Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 Product Usage: Knee joint patellofemorotibial polymer/metal/polymer... on 2019-03-13. FDA classified it as Class II and gives the reason as "2.5 Truliant Fit Trays were mismarked as 3". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1208-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-13
Posted: 2019-04-23
Terminated: 2021-04-22
Recalling firm: Exactech, Inc.
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.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: 2.5 Truliant Fit Trays were mismarked as 3
FDA root cause: Under Investigation by 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.
Quantity in commerce: 18 units
Distribution: US Nationwide Distribution in the states of AR, CA, OH, OK, IN, MN, NJ, TN, SC, FL
Product codes and lots: Serial Numbers: 5774515, 5774517, 5774518, 5774519, 5774520, 5774521, 5774525, 5774526, 5774527, 5774529, 5774531, 5774532, 5774533, 5774534, 5774535, 5774541, 5774543

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1208-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1208-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-01	2019-04-23

Product code JWH

K152170Class IIExactech Optetrak Logic Enhanced AssemblyExactech, Inc. / cleared 2015-09-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)