DePuy Orthopaedics, Inc.: 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

Is my product affected?

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 stabili

• UPC 10603295224389

Check against the official notice below — it lists the full affected range.

What happened

The DePuy Orthopaedics I.M. Hole Locator Instrument is an orthopedic manual surgical instrument used to guide the IM drill during IM Hole preparation. The device is being recalled because use of excessive force when impacting may lead to intra-operative femoral fracture. Approximately 1,130 units with catalog number 9505-01-041 have been distributed worldwide, including throughout the United States and in Canada, Australia, Austria, Belgium, Czech Republic, France, Germany, India, Israel, Italy, Japan, Malaysia, Russia, South Africa, Switzerland, and the United Kingdom.

The recall affects all lots of this instrument. The source document does not specify a remedy or recommended course of action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Use of excessive force when impacting may lead to intra-operative femoral fracture. Distribution: 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. Quantity: 1130 Lot/code info: CATALOG NO. : 9505-01-041 Barcode GTIN: 10603295224389 ALL LOTS

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• BrightView model number: 882478 BrightView X model number: 882480 BrightView XCT model number: 882482 and 882454 Medical Device for imaging2014-11-12
• Fixed Tibial bearing ATTUNE INTUITION Impactor The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its relevant mating part: 2014-11-10
• Rotating Tibial Platform ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its relevant mating p2014-11-10
• Femoral Impactor ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its relevant mating part: Fix2014-11-10
• The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacement procedures. The instrument interfaces with several related ATTUNE instruments: keel punch, tibial tower, evaluation bullet, fixed bearing tibial impactor, rotating platform tibial impactor, and femoral impa2014-11-10

All FDA (Device enforcement) recalls