CLASS II ONGOING Device recall · Reported 12 Nov 2025 · FDA Enforcement Report
Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene I.D recalled
Zimmer is recalling Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene I.D, distributed in 20 states. The recall was initiated on 26 Sep 2025 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-0419-2026
- FDA event ID
- 97765
- Recalling firm
- Zimmer, Warsaw, IN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Sep 2025
- FDA classified
- 3 Nov 2025
- Reported
- 12 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Hip & Knee Implants
Timeline
| 26 Sep 2025 | Recall initiated by company | |
| 3 Nov 2025 | Classified by FDA | +38 days |
| 12 Nov 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.
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
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing, Model/Catalog Number: 110031013; semi constrained hip prosthesis
Where it was distributed
US: OH, GA, WI, NE, IA, IL, CA, NY, MD, NC, PA, AL, TN, MI, WA, FL, TX, KS, NM, AZ, and CANADA, AUSTRALIA, NETHERLANDS
AlabamaArizonaCaliforniaFloridaGeorgiaIowaIllinoisKansasMarylandMichiganNorth CarolinaNebraskaNew MexicoNew YorkOhioPennsylvaniaTennesseeTexasWashingtonWisconsin
Questions about this recall
Is Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene I.D recalled?
Yes. Zimmer recalled Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene I.D on 26 Sep 2025. The recall is Class II and its status is Ongoing. Recall number Z-0419-2026.
Why was it recalled?
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.
Which lots are affected?
UDI (01)00889024572713(17)300406(10)67160480; Lot Number 67160480
Where was it sold?
US: OH, GA, WI, NE, IA, IL, CA, NY, MD, NC, PA, AL, TN, MI, WA, FL, TX, KS, NM, AZ, and CANADA, AUSTRALIA, NETHERLANDS
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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|---|---|---|---|---|---|
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| Device | CLASS II | Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment recalled | Zimmer | Foreign Material | IN |
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Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |