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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80583

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

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Event summary

Timeline bucket
July 24, 2017
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Richard Wolf GmbH

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

Artholine Punch B 4, 6MM H 1, 6MM, used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural or surgically created passages. Product Usage: Device is a standard punch; standard punches are used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural or surgically created passages.

Z-2897-2018
Recall number
Z-2897-2018
Initiated
July 24, 2017
Classification
Class II
Status
Ongoing
Recalling firm
Richard Wolf GmbH
Quantity
12 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Punch may have a burr in one section of the joint and when the punch is open, there is an increase potential for injury.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

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Inspect official wording and provenance

Reason for recall

Punch may have a burr in one section of the joint and when the punch is open, there is an increase potential for injury.

Code information

Product Number 89140.0105, Lot Number 4500197481

Distribution pattern

Worldwide distribution to Germany, Hong Kong, Ireland, Romania, and Turkey.