Device recall: Brand Name: Persona Revision Product Name: Persona Revision Trabecular Metal Femoral Distal Augment Model/Catalog…

Class II FDA enforcement event 99073. Recall start date: 11 May 2026. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Zimmer, Inc. started this device recall on 11 May 2026. The firm address in the FDA record is in Warsaw, IN. FDA put the recall in Class II. FDA event 99073 has 1 product record. The first FDA enforcement report date is 1 Jul 2026. The record gives the status Ongoing.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Refer to the attached ZFA 2026-00088_Initial Consignee List and ZFA 2026-00088_Initial Distribution History containing the distribution and the identification of the affected consignees.

Recalling firm

Zimmer, Inc., Warsaw, IN.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 99073: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2578-2026	Brand Name: Persona Revision Product Name: Persona Revision Trabecular Metal Femoral Distal Augment Model/Catalog Number: 42-5572-066-10 Software Version: N/A Product Description: Persona Revision Trabecular Metal Femoral Distal Augment Size 9, 9+ 10mm Thicknes Component: N/A	12	Class II	Ongoing	1 Jul 2026

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2026: 572
Share of these events in Class II: 87%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 108

Other events of the firm

Other FDA enforcement events of Zimmer, Inc.
Initiated	Product (first record)	Type	Class	Records
20 May 2026	Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240	Device	Class II	5
30 Mar 2026	Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011	Device	Class II	1
2 Dec 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:	Device	Class II	17
26 Sep 2025	Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Ca	Device	Class II	2
24 Mar 2025	Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prosthesis, Hip, Semi-Constr	Device	Class II	5
27 Feb 2025	NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number	Device	Class II	1
12 Feb 2025	Z1 Femoral Hip System, Product Number 611777612	Device	Class II	1
6 Jan 2025	NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14	Device	Class II	2
17 Sep 2024	Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access fo	Device	Class II	1
2 Jul 2024	CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000 008	Device	Class II	1

Zimmer, Inc.: all 108 events

Official channels

FDA enforcement report Z-2578-2026The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 99073. https://recallregister.com/fda/ii/99073/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Refer to the attached ZFA 2026-00088_Initial Consignee List and ZFA 2026-00088_Initial Distribution History containing the distribution and the identification of the affected consignees.
What quantity of product is in FDA event 99073?: The FDA record gives this quantity: 12
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2026 have the same class?: 87% of the 572 device events that started in 2026 are in Class II.