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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84397

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

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Event summary

Timeline bucket
November 04, 2019
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

Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage: The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.

Z-0775-2020
Recall number
Z-0775-2020
Initiated
November 04, 2019
Classification
Class II
Status
Terminated
Recalling firm
Medacta Usa Inc
Quantity
207 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain lot numbers of the Medacta Humeral Anatomical Cementless Metaphysis have a dimensional condition that could limit insertion of the screw used to lock the metaphysis to the humeral diaphysis.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain lot numbers of the Medacta Humeral Anatomical Cementless Metaphysis have a dimensional condition that could limit insertion of the screw used to lock the metaphysis to the humeral diaphysis.

Code information

GTIN 07630040712613 REF # Lot 04.01.23 184523 04.01.23 184523 04.01.23 184523 04.01.23 184523 04.01.23 184523 04.01.23 184523 04.01.24 184524 04.01.24 184524 04.01.24 184524 04.01.25 184525 04.01.25 184525 04.01.25 184525 04.01.26 184526 04.01.26 184526 04.01.26 184526 04.01.27 184527 04.01.27 184527 04.01.27 184527 04.01.27 1901138 04.01.27 1901138 04.01.27 1901138 04.01.27 1901138 04.01.28 184528 04.01.28 184528 04.01.28 1901139 04.01.29 184529 04.01.29 184529 04.01.29 184529 04.01.29 184529 04.01.29 184529 04.01.29 184529 04.01.30 184530 04.01.30 184530 04.01.31 184531 04.01.31 184531 04.01.31 184531 04.01.31 184531 04.01.31 184531 04.01.32 184532 04.01.33 184533 04.01.33 184533 04.01.33 184533 04.01.33 184533 04.01.33 184533 04.01.33 184533 04.01.34 184534 04.01.34 184534 04.01.34 184534 04.01.34 184534 04.01.35 184535 04.01.35 184535 04.01.35 184535 04.01.35 184535 04.01.35 184535 04.01.35 184535 04.01.35 184535 04.01.36 184536 04.01.36 184536 04.01.36 184536 04.01.36 184536 04.01.36 184536 04.01.36 184536 04.01.36 184536 04.01.37 184537 04.01.37 184537 04.01.37 184537 04.01.37 184537 04.01.37 184537 04.01.37 184537 04.01.37 184537 04.01.38 184538 04.01.38 184538 04.01.38 184538 04.01.38 184538 04.01.38 184538 04.01.39 184539 04.01.39 184539 04.01.39 184539 04.01.39 184539 04.01.39 184539 04.01.39 184539 04.01.40 184540 04.01.40 184540 04.01.41 184541 04.01.41 184541 04.01.41 184541 04.01.41 184541 04.01.41 184541 04.01.41 184541 04.01.43 184543 04.01.43 184543 04.01.43 184543 04.01.44 184544 04.01.44 184544 04.01.44 184544 04.01.45 184545 04.01.45 184545 04.01.45 184545 04.01.45 184545 04.01.45 184545 04.01.45 184545 04.01.46 184546 04.01.46 184546 04.01.46 184546 04.01.47 184547 04.01.47 184547 04.01.48 184548 04.01.48 184548 04.01.49 184549 04.01.49 184549 04.01.50 184550 04.01.50 184550 04.01.52 184552 04.01.53 184553 04.01.53 184553 04.01.53 184553 04.01.54 184554 04.01.54 184554 04.01.54 184554 04.01.55 184555 04.01.55 184555

Distribution pattern

US Nationwide distribution in the states of KY, NJ, IL, SC, CA, TX, ID, AR, OH.

Field note

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