Z-0908-2015 Class II Terminated
FDA device recall Z-0908-2015 was initiated by DePuy Orthopaedics, Inc. on Nov 12, 2014 and is designated Class II. Reason for recall: Use of excessive force when impacting may lead to intra-operative femoral fracture. The recall status is terminated (terminated Feb 24, 2015). Affected quantity: 1130.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 14, 2015
- Initiation Date
- Nov 12, 2014
- Termination Date
- Feb 24, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1130
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.
Reason for Recall
Use of excessive force when impacting may lead to intra-operative femoral fracture.
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.
Code Information
CATALOG NO. : 9505-01-041 Barcode GTIN: 10603295224389 ALL LOTS
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0908-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026