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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93024

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

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Event summary

Timeline bucket
August 29, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Flower Orthopedics Corporation

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

Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary canal to the appropriate depth for nail insertion; Flex-Thread TM 3.2mm is provided sterile, single use. Catalogue Number: 8528-1-S

Z-0074-2024
Recall number
Z-0074-2024
Initiated
August 29, 2023
Classification
Class II
Status
Ongoing
Quantity
70 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Device is breaking while in use, potential for patients to require a revision surgery.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device is breaking while in use, potential for patients to require a revision surgery.

Code information

UDI:00840118117432 Lot Number: 2304323076

Distribution pattern

US Nationwide distribution.