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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88636

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

Open FDA event record

Event summary

Timeline bucket
September 13, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Innovative Orthopedic Technologies, 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

ARCH Leg Positioning System

Z-0072-2022
Recall number
Z-0072-2022
Initiated
September 13, 2021
Classification
Class II
Status
Terminated
Quantity
10 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to the holes not being bored to the specific diameter, the locking pins are unable to engage under a load.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to the holes not being bored to the specific diameter, the locking pins are unable to engage under a load.

Code information

Model: 6813010 Serial Numbers: 6813010.0066; 6813010.0067; 6813010.0069; 6813010.0070; 6813010.0071; 6813010.0072; 6813010.0073; 6813010.0074; 6813010.0075; 6813010.0076;

Distribution pattern

U.S. Nationwide distribution in the states of AL, AZ, FL, MI, MN, OK, SD, and TX.