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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91091

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 27, 2022
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Medacta Usa Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platform used to perform a reverse shoulder arthroplasty on the glenoid

Z-0372-2023
Recall number
Z-0372-2023
Initiated
October 27, 2022
Classification
Class II
Status
Terminated
Recalling firm
Medacta Usa Inc
Quantity
14 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A warning has been added to the Surgical Technique for NextAR Shoulder, advising verification of suitable patient conditions prior to placement of the NextAR Shoulder Target Holder: WARNING Target fixation requires adequate coracoid bone stability. Osteoporosis, weakness of the coracoid process, or other deficiencies, could lead to adverse events including bone fracture. Verify that the coracoid bone and relevant patient conditions are suitable before proceeding.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

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Inspect official wording and provenance

Reason for recall

A warning has been added to the Surgical Technique for NextAR Shoulder, advising verification of suitable patient conditions prior to placement of the NextAR Shoulder Target Holder: WARNING Target fixation requires adequate coracoid bone stability. Osteoporosis, weakness of the coracoid process, or other deficiencies, could lead to adverse events including bone fracture. Verify that the coracoid bone and relevant patient conditions are suitable before proceeding.

Code information

Document Reference Code 99.81NEXTAR.12US (for US market only), Revision Numbers: Rev.02 and previous

Distribution pattern

AL, FL, NH, CO, IL, SC, AR

Field note

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