DePuy Orthopaedics, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0908-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 12, 2014

Date Posted: January 14, 2015

Recall Number: Z-0908-2015

Event ID: 70046

Reason for Recall:

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

Status: Terminated

Product Quantity: 1130

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.

Voluntary or Mandated:

Voluntary: Firm initiated