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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70722

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

Open FDA event record

Event summary

Timeline bucket
February 13, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Exactech, 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

Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.

Z-1459-2015
Recall number
Z-1459-2015
Initiated
February 13, 2015
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
112 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrectly packaged. Outer and inner labeling may incorrectly identify the size of the enclosed device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrectly packaged. Outer and inner labeling may incorrectly identify the size of the enclosed device.

Code information

Serial Numbers 3597678 thru 3597713, 3609323 thru 3609358, 3616214 thru 3616249 and 3640539 thru 3640574.

Distribution pattern

Worldwide Distribution - US Nationwide in the states of AK, AZ, CA, CO, FL, ID, ME, MN, NC, OH, OK, PA, RI, TN, VA and WA. and countries of Brazil and Canada.