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Recall Observatory FDA recall evidence

Device product

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

November 12, 2014

Class II

Product summary

Firm
DePuy Orthopaedics, Inc.
Event
Event 70046
Status
Terminated
Classification
Class II
Quantity
1130
Official record key
device-enforcement:Z-0908-2015

Official wording

Reason: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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