Z-2128-2016Class II

Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 18. Femoral stems...

Name: Z-2128-2016 Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 18. Femoral stems...
Creator: Exactech, Inc.
Published: 2016-05-26
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2016-05-26 / Terminated / root cause: labeling and UDI

FDA source

Exactech, Inc. began a recall of Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 18. Femoral stems are indicated for use in skeletally mature... on 2016-05-26. FDA classified it as Class II and gives the reason as "Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2128-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-26
Posted: 2016-07-05
Terminated: 2019-07-26
Recalling firm: Exactech, Inc.
Product: Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 18. Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and proximal femoral fractures. Also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. Intended for press-fit fixation.
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Exatech sent an Important Notification letter dated May 16, 2016, to all affected customers. The letter notified customers of the product's incorrect Global Trade Item Number. Customers were instructed to cease distribution/use of the product, extend the information to accounts possessing the recalled product, identify and quarantine any devices in inventory, and to complete and return the Recall Inventory Response Form acknowledging that they received the recall notification. Customers were instructed to call 800-392-2832 with any questions. For questions regarding this recall call 352-377-1140.
Quantity in commerce: 14
Distribution: Nationwide Distribuiton to OK, ME, NY, & Hawaii.
Product codes and lots: Catalog #: 160-33-18; Serial#: 4300062, 4300063; Exp Date: 02/27/2021. Catalog #: 160-33-18; Serial#:4325742, 4325743, 4325744, 4325745, 4325746, 4325747, 4325748, 4325749, 4325750, 4325751, 4325752, 4325753; Exp Date: 03/17/2021.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2128-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2127-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-13	2016-07-05
Z-2128-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-13	2016-07-05

Product code LZO

K063279Class IINovation Splined Rdd Femoral StemsExactech, Inc. / cleared 2006-11-29

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)