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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90603

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

Open FDA event record

Event summary

Timeline bucket
July 29, 2021
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Mizuho OSI

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

HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144

Z-1573-2022
Recall number
Z-1573-2022
Initiated
July 29, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Mizuho OSI
Quantity
13 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number.

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

One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number.

Code information

Model Number: 6850-144 UDI Code: (01)00842430106842(10)MIZ210712(11)210712 Lot/Batch Number: MIZ210712

Distribution pattern

U.S Nationwide Distribution .: CA, FL, GA, MI, NE, NJ, TN, UT, and WA O.U.S.: Canada