Z-0788-2013Class II

Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF...

Name: Z-0788-2013 Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF...
Creator: Exactech, Inc.
Published: 2012-11-05
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2012-11-05 / Terminated / root cause: labeling and UDI

FDA source

Exactech, Inc. began a recall of Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 136-32-53. Exactech Hip Systems are indicated for use... on 2012-11-05. FDA classified it as Class II and gives the reason as "Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the device labeling was...". 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-0788-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-05
Posted: 2013-02-05
Terminated: 2013-12-24
Recalling firm: Exactech, Inc.
Product: Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 136-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement.
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the device labeling was inadvertently transposed.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Exactech, Inc. notified consignees by telephone on 11/05/12 of the affected devices and sent an "IMPORTANT PRODUCT RECALL NOTICE" letter dated 11/06/12. The letter describes the purpose of the recall, the product affected, the problem and actions to be taken by the consignees. A Product Recall Response Form was attached for the consignees to contact the Exactech inventory representative within 5 business days to confirm quantities of product in their inventory and return them to Exactech. Consignees with any questions relating to these devices should call 1-800-392-2832.
Quantity in commerce: 26 Units
Distribution: Distributed in the states of TN, FL, VA, WA and NV.
Product codes and lots: Catalog No. 130-3253, Serial Numbers 2479944 - 2479969 and Catalog No. 136-32-53, Serial Numbers 2479873 - 2479898.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0788-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0787-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-13	2013-02-05
Z-0788-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-13	2013-02-05

Product code LZO

K070479Class IIExactech Novation Crown Cup and LinersExactech, Inc. / cleared 2007-03-15

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)