Recall Z-0908-2015— DePuy Orthopaedics, Inc.
Class II · Terminated
Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2014-11-12, terminated 2015-02-24. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Use of excessive force when impacting may lead to intra-operative femoral fracture..
- Recalling firm
- DePuy Orthopaedics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-11-12
- Terminated
- 2015-02-24
- Firm location
- Warsaw, IN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.