Z-1900-2016Class II

Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabular Cup), Catalog Number...

Name: Z-1900-2016 Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabular Cup), Catalog Number...
Creator: Exactech, Inc.
Published: 2016-04-12
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2016-04-12 / Terminated / root cause: packaging

FDA source

Exactech, Inc. began a recall of Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabular Cup), Catalog Number 140-01-54; For use in primary total hip arthroplasty on 2016-04-12. FDA classified it as Class II and gives the reason as "Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1900-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-12
Posted: 2016-06-02
Terminated: 2019-07-24
Recalling firm: Exactech, Inc.
Product: Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabular Cup), Catalog Number 140-01-54; For use in primary total hip arthroplasty.
Product code: MRA Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
Reason for recall: Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Customers were notified 4/12/2016 with a Product Recall Advisory Notice of affected products.In order to comply with applicable regulations and Exactech policies: " Immediately cease distribution or use of these products. " Extend this information to your accounts that may have this product in their possession. " Identify and quarantine any of the subject devices in your inventory " Complete and Return the attached Recall Inventory Response Form to Exactech, per the instructions provided on the notice itself. According to policy, please contact your Exactech inventory representative within 5 business days to confirm quantities at your location. If you have any inventory restocking questions related to this issue, please contact Kaya Davis at [email protected] or 1-800-392-2832. Please return the products to the following address: Exactech Distribution Center 2411 NW 66th Court Gainesville, Florida 32653 Attention: Kaya Davis [email protected] 352-337-3915 (Fax)
Quantity in commerce: 3 devices
Distribution: Distributed in FL, NJ, NY, OH, OK, RI, TN, VA and HI.
Product codes and lots: Product Code: MRA; Catalog Number 140-01-54, Serial Numbers: 4296076, 4296078, 4296079, Exp. 2/23/2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1900-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1900-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-06-02
Z-1901-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-06-02
Z-1902-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-06-02
Z-1903-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-06-02
Z-1904-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-06-02
Z-1905-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-06-02

Product code MRA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)