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U.S. Department of Health and Human Services

Class 2 Device Recall HP LCS IM Hole Locator instrument

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  Class 2 Device Recall HP LCS IM Hole Locator instrument see related information
Date Initiated by Firm November 12, 2014
Date Posted January 05, 2015
Recall Status1 Terminated 3 on February 24, 2015
Recall Number Z-0908-2015
Recall Event ID 70046
Product Classification Orthopedic manual surgical instrument - Product Code LXH
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.
Code Information CATALOG NO. : 9505-01-041 Barcode GTIN: 10603295224389 ALL LOTS
Recalling Firm/
Manufacturer		 DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact Kimberly C. Earle
574-371-4917
Manufacturer Reason
for Recall		 Use of excessive force when impacting may lead to intra-operative femoral fracture.
FDA Determined
Cause 2		 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 via fax to (574) 371-4939 or email: kearle@its.jnj.com. For questions, please contact Recall Coordinator, at 574-371-4917 (M-F; 8 a.m. - 5 p.m. EST).
Quantity in Commerce 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, Russia, South Africa, Switzerland, and United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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