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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69294

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

Open FDA event record

Event summary

Timeline bucket
September 19, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Orthohelix Surgical Designs 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

MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during procedures to clear away bone and cartilage within the desired implant area.

Z-0062-2015
Recall number
Z-0062-2015
Initiated
September 19, 2014
Classification
Class II
Status
Terminated
Quantity
38

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer

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

Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer

Code information

Part Number: MFT-074-CC-24; Lot: 3164011

Distribution pattern

USA Distribution -- in the states of WI, NM, TX, WA, MO, OH, UT, TN, MI, VA, NC, VA, and PA.