Device 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.
Z-0908-2015
Product summary
- Event
- Event 70046
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1130
- Official record key
device-enforcement:Z-0908-2015
Official wording
Reason: Use of excessive force when impacting may lead to intra-operative femoral fracture.
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.
Derived failure modes
-
Unknown
Use of excessive force when impacting may lead to intra-operative femoral fracture.