Recall Z-0908-2015 ยท LXH Orthopedic Manual Surgical Instrument
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 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
| Date | Jan 5, 2015 (initiated Nov 12, 2014) |
| Status | Terminated |
| Reason | Use of excessive force when impacting may lead to intra-operative femoral fracture. |
| Root cause | Device Design |
| Action | The firm, DePuy Synthes, sent an "URGENT INFORMATION - DEVICE CORRECTION NOTICE HP LCS IM Hole Locator" notification dated November 12, 2014 to the affected distributors. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The distributors were instructed to: review the instructions and the information in this notice; provide this notice to your sales consultants, and complete and return the DISTRIBUTOR RESPONSE CARD: Verify Sales Consultant Notifications v |
| Quantity | 1130 |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.