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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89984

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

Open FDA event record

Event summary

Timeline bucket
March 25, 2022
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Arthrex, 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

K-Wire, 1.35 mm x 170 mm

Z-1035-2022
Recall number
Z-1035-2022
Initiated
March 25, 2022
Classification
Class II
Status
Terminated
Recalling firm
Arthrex, Inc.
Quantity
300 pieces

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Products do not meet length and diameter specifications.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products do not meet length and diameter specifications.

Code information

Part Number: AR-8610K-43, Batch 1298116640 UDI: 00888867197084

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of OH, TN, MO, LA, IA, AZ, PA, NY, OR and the countries of to Belgium, Egypt, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Portugal, and Spain.