CLASS II ONGOING Device recall · Reported 1 Jul 2026 · FDA Enforcement Report
Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment recalled
Zimmer is recalling Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment. The recall was initiated on 11 May 2026 and the FDA has classified it as Class II.
Check your package
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-2578-2026
- FDA event ID
- 99073
- Recalling firm
- Zimmer, Warsaw, IN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 May 2026
- FDA classified
- 24 Jun 2026
- Reported
- 1 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Hip & Knee Implants
Timeline
| 11 May 2026 | Recall initiated by company | |
| 24 Jun 2026 | Classified by FDA | +44 days |
| 1 Jul 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.
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
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
Where it was distributed
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.
Questions about this recall
Why was it recalled?
Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.
Which lots are affected?
Lot Code: Model No. 42-5572-066-10 ; UDI-DI (01)00889024561014(17)331103(10)66232947 ; Lot number 66232947
Where was it sold?
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 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 26 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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