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fda_recall · device_recall · high

Zimmer, Inc. — Class II recall: Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D…

Event date
2025-11-12 00:00:00Z
Observed
2026-07-16 23:20:10Z
Source ID
Z-0419-2026
Payload hash
49663efa7370105efa77dad2

Summary

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. Status: Ongoing.

Entities

Frequently asked questions

Has Zimmer, Inc. had other FDA enforcement actions?
Yes. Argus HQ has recorded 64 total FDA actions tied to Zimmer, Inc.: 0 warning letters, 64 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?
This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2025-11-12; Argus observed and indexed it on 2026-07-16.
Where can I verify this record directly with FDA?
The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA
Argus HQ Research (2025). Zimmer, Inc. — Class II recall: Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-zimmer-inc-z-0419-2026
MLA
"Zimmer, Inc. — Class II recall: Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D…." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/events/fda-recall-zimmer-inc-z-0419-2026.
Chicago
Argus HQ Research. "Zimmer, Inc. — Class II recall: Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D…." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-zimmer-inc-z-0419-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_zimmer_inc_z_0419_2026_2025,
  title = {Zimmer, Inc. — Class II recall: Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D…},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-zimmer-inc-z-0419-2026},
  note = {Accessed: July 17, 2026}
}

Informational only. Not legal, financial, or medical advice.