The Recall Desk
SevereFDA (Devices)·Z-0908-2015·Announced 2015-01-14

DePuy I.M. Hole Locator Instrument Recalled for Fracture Risk

DePuy Orthopaedics is recalling 1,130 I.M. Hole Locator Instruments because excessive force during use may lead to intra-operative femoral fracture.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of significant injury (intra-operative femoral fracture), which aligns with the 'Severe' criteria for significant injury reports or high-risk structural defects.

Plain-English summary

DePuy Orthopaedics, Inc. is recalling 1,130 units of the I.M. Hole Locator Instrument. This is an orthopedic manual surgical instrument used to guide the IM drill during IM Hole preparation. The instrument is positioned between the condyles and aligned with the anatomical axis.

The recall is issued because the use of excessive force when impacting the instrument may lead to intra-operative femoral fracture. The affected units are identified by Catalog No. 9505-01-041 and Barcode GTIN 10603295224389, covering all lots.

The products were distributed worldwide, including nationwide in the United States and in countries such as Canada, Australia, Austria, Belgium, the Czech Republic, France, Germany, India, Israel, Italy, Japan, Malaysia, Russia, South Africa, Switzerland, and the United Kingdom. Healthcare providers should stop using the affected instruments and contact DePuy Orthopaedics for further instructions.

The recalled product

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 as
Manufacturer
DePuy Orthopaedics, Inc.
Category
Medical Device — Orthopedic Surgical Instrument
Hazard
Affected units
1,130

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

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

Distribution

Distributed nationwide across the United States.

The notice also names 27 states specifically:

Related recalls

Same manufacturer · DePuy Orthopaedics, Inc.

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