I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. The IM Hole locator guides the IM drill during IM H

FDA device recall Z-0908-2015 · posted 2015-01-05 · Terminated

Recall details

Recalling firm

DePuy Orthopaedics, Inc.

Reason for recall

Use of excessive force when impacting may lead to intra-operative femoral fracture.

Action taken

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).

Root cause

Device Design

Status

Terminated

Product code

LXH

Quantity affected

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, A

Date initiated

2014-11-12

Date posted

2015-01-05

Date terminated

2015-02-24

Location

Warsaw, IN