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fda_recall · device_recall · high

Zimmer GmbH — Class II recall: Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in t…

Event date
2024-09-18 00:00:00Z
Observed
2026-07-16 23:20:10Z
Source ID
Z-3132-2024
Payload hash
1bb5e961133cd6bd1fce35df

Summary

Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etching as either STD or -6 Status: Ongoing.

Entities

Frequently asked questions

Has Zimmer GmbH had other FDA enforcement actions?
Yes. Argus HQ has recorded 2 total FDA actions tied to Zimmer GmbH: 0 warning letters, 2 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 2024-09-18; 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 (2024). Zimmer GmbH — Class II recall: Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in t…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-zimmer-gmbh-z-3132-2024
MLA
"Zimmer GmbH — Class II recall: Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in t…." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/events/fda-recall-zimmer-gmbh-z-3132-2024.
Chicago
Argus HQ Research. "Zimmer GmbH — Class II recall: Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in t…." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-zimmer-gmbh-z-3132-2024.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_zimmer_gmbh_z_3132_2024_2024,
  title = {Zimmer GmbH — Class II recall: Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in t…},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-zimmer-gmbh-z-3132-2024},
  note = {Accessed: July 17, 2026}
}

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