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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70046

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

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Event summary

Timeline bucket
November 12, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
DePuy Orthopaedics, 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

I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. The IM Hole locator guides the IM drill during IM Hole preparation. The instrument is positioned between the condyles and aligned with the anatomical axis. Pins can be placed in the IM hole locator to assist with additional stability. The drill bush may also be lightly impacted onto the distal femur for additional stability.

Z-0908-2015
Recall number
Z-0908-2015
Initiated
November 12, 2014
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
1130

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Use of excessive force when impacting may lead to intra-operative femoral fracture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

Reason for recall

Use of excessive force when impacting may lead to intra-operative femoral fracture.

Code information

CATALOG NO. : 9505-01-041 Barcode GTIN: 10603295224389 ALL LOTS

Distribution pattern

Worldwide Distribution: US (nationwide) including states of: AZ, CA, CO, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MT, NC, NV, NY, OH, PA, TN, TX, VA, WA, and WI; and countries of: Canada, Australia, Austria, Belgium, Czech Republic, France, Germany, India, Israel, Italy, Japan, Malaysia, Russia, South Africa, Switzerland, and United Kingdom.