RecallRadar

FDA Device recall Z-0908-2015

I.M. Hole Locator Instrument

On 2015-01-14 the FDA classified a Class II recall of I.M. Hole Locator Instrument by Depuy Orthopaedics, citing use of excessive force when impacting may lead to intra-operative femoral fracture.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0908-2015
ClassificationClass II
Statusterminated
Initiated2014-11-12
Published2015-01-14
Last updated2026-09-13 11:53 UTC
CompanyDepuy Orthopaedics
DistributionUS

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.

Reason

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

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0908-2015%22

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