Exact FDA event identifier

Event 84770

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

Open FDA event record

Event summary

Timeline bucket: October 02, 2019
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Medicrea International

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

Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010

Z-1156-2020

Recall number: Z-1156-2020
Initiated: October 02, 2019
Classification: Class II
Status: Terminated
Recalling firm: Medicrea International
Quantity: 14 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the inserter

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the inserter

Code information

Lot Numbers l9B0570; 19B0572

Distribution pattern

OH, VA