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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75855

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

Open FDA event record

Event summary

Timeline bucket
November 22, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Amendia, 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

Zeus-P Lumbar Interbody Device

Z-0827-2017
Recall number
Z-0827-2017
Initiated
November 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Amendia, Inc
Quantity
25 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling error where three boxes in inventory had conflicting patient and primary labels. Evaluation indicated that the primary label and patient label did not match. The primary label matched the label on the inner pouch, but the patient label was incorrect.

Code information

Part Number 1-110926B - Lot Number 128945 and Part Number 1-120922B - Lot Number 128946

Distribution pattern

US Distribution to the states of : GA. MI, OK, SC, TX, VA