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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89443

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

Open FDA event record

Event summary

Timeline bucket
December 14, 2021
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

Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical procedures Product Number: 72205104

Z-0635-2022
Recall number
Z-0635-2022
Initiated
December 14, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
271 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process

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 were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process

Code information

Lot Numbers: 50971615, 50971617 & 50967788

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of CO, CT, FL, MA, MD, OR, PA, WI and the country of Canada.