Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip system componen

FDA device recall Z-2644-2017 · posted 2017-06-19 · Terminated

Recall details

Recalling firm

Exactech, Inc.

Reason for recall

The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to perform calcar planing to the bone, i.e., to include a caution statement about the potential for instrument breakage if bending or torsional forces are applied.

Action taken

Exactech sent an Field Advisory Notice dated May 22, 2017, by mail informing the customers the updated surgical technique is available on Exactech's website (www.exac.com). The notice requested consignees: Extend the information to accounts in possession of the product Complete & return the attached Field Advisory Notice Response Form to Exactech. For further questions, please call (800) 392-2832.

Root cause

Under Investigation by firm

Status

Terminated

Product code

LXH

Quantity affected

477

Distribution

Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MN, NC, NJ, NV, NY, OH, OK, OR, RI,

Date initiated

2017-05-22

Date posted

2017-06-19

Date terminated

2019-07-26

Location

Gainesville, FL