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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91109

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

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Event summary

Timeline bucket
October 20, 2022
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
CoreLink LLC

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

CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208

Z-0954-2023
Recall number
Z-0954-2023
Initiated
October 20, 2022
Classification
Class II
Status
Terminated
Recalling firm
CoreLink LLC
Quantity
18 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy.

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

Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy.

Code information

UDI/DI M725AT32080, Lot Codes: SM135217, SM129260

Distribution pattern

US Nationwide distribution.