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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95654

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

Open FDA event record

Event summary

Timeline bucket
October 29, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Smith & Nephew 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

BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.

Z-0581-2025
Recall number
Z-0581-2025
Initiated
October 29, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew Inc.
Quantity
2,156 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate packaging
Sterility assurance reason.sterility_assurance · v1.0.0
Sterile barrier breach

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.

Code information

Part No. 72201541, 72201542, 72203280, 72203281; UDI-DI: 03596010595072, 03596010595089, 03596010656452, 03596010656469; Batch No. 2146369, 2151242, 2151690, 2154691, 2153489, 2151692.

Distribution pattern

Worldwide - US Nationwide distribution in the states of AK, AL, IL, IN, KY, MD, MN, NC, NE, NH, NJ, TX and the countries of CA, CL, CN, EC, ES, GB, KZ, NO, PE, PL, RU, TR.