fda_recall · device_recall · high

Medacta Usa Inc — Class II recall: Short Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971, 9/0…

Event date
2026-07-08 00:00:00Z
Observed
2026-07-14 04:20:26Z
Source ID
Z-2618-2026
Payload hash
995576c4a69c123f1bb34a15

Summary

Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the reaming guide and the stem reamer are positioned approximately 0.2 mm per size more laterally than intended, which may increase the risk of fracture in the medial… Status: Ongoing.

Frequently asked questions

Has Medacta Usa Inc had other FDA enforcement actions?
This is the only FDA action Argus HQ has on file for Medacta Usa Inc as of 2026-07-14. Argus ingests new FDA enforcement records daily.
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 2026-07-08; Argus observed and indexed it on 2026-07-14.
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 (2026). Medacta Usa Inc — Class II recall: Short Monobloc Stem Broaches, Size/REF:  7/04.01.10.0970,  8/04.01.10.0971,  9/0…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-medacta-usa-inc-z-2618-2026
MLA
"Medacta Usa Inc — Class II recall: Short Monobloc Stem Broaches, Size/REF:  7/04.01.10.0970,  8/04.01.10.0971,  9/0…." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/events/fda-recall-medacta-usa-inc-z-2618-2026.
Chicago
Argus HQ Research. "Medacta Usa Inc — Class II recall: Short Monobloc Stem Broaches, Size/REF:  7/04.01.10.0970,  8/04.01.10.0971,  9/0…." Digital Empire LLC. Accessed July 14, 2026. https://argushq.ai/events/fda-recall-medacta-usa-inc-z-2618-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_medacta_usa_inc_z_2618_2026_2026,
  title = {Medacta Usa Inc — Class II recall: Short Monobloc Stem Broaches, Size/REF:  7/04.01.10.0970,  8/04.01.10.0971,  9/0…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-medacta-usa-inc-z-2618-2026},
  note = {Accessed: July 14, 2026}
}

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