CLASS II Device recall · Reported 8 Jun 2016 · FDA Enforcement Report

Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, O.D recalled

Exactech is recalling Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, O.D, distributed in 9 states. The recall was initiated on 12 Apr 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code: MRA, Catalog Number 140-01-56, Serial Numbers: 4268399 and 4268400, Exp. 2/6/2021.

Quantity recalled2 devices.

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1901-2016
FDA event ID: 73200
Recalling firm: Exactech, Gainesville, FL
Classification: Class II
Status: Terminated
Recall initiated: 12 Apr 2016
FDA classified: 2 Jun 2016
Reported: 8 Jun 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Hip & Knee Implants

Timeline

12 Apr 2016	Recall initiated by company
2 Jun 2016	Classified by FDA	+51 days
8 Jun 2016	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup), Catalog Number 140-01-56; For use in primary total hip arthroplasty.

Where it was distributed

Distributed in FL, NJ, NY, OH, OK, RI, TN, VA and HI.

Florida Hawaii New Jersey New York Ohio Oklahoma Rhode Island Tennessee Virginia

Questions about this recall

Is Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, O.D recalled?

Yes. Exactech recalled Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, O.D on 12 Apr 2016. The recall is Class II and its status is Terminated. Recall number Z-1901-2016.

Why was it recalled?

Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.

Which lots are affected?

Product Code: MRA, Catalog Number 140-01-56, Serial Numbers: 4268399 and 4268400, Exp. 2/6/2021.

Where was it sold?

Distributed in FL, NJ, NY, OH, OK, RI, TN, VA and HI.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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