VER2 HANDLE, PIN REWORK, LT Nonsterile

FDA device recall Z-2228-2014 · posted 2014-08-14 · Terminated

Recall details

Recalling firm

Zimmer, Inc.

Reason for recall

The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

Action taken

On July 23, 2014, Zimmer issued recall notification to their consignees. Distributors were notified via electronic mail and courier. Recall notification included a description of the issue, affected product, possible risks to patient, and instructions for responding to the recall. Questions or concerns regarding the recall are directed to Zimmer customer call center @ 1-800-348-2759 M-F, 8am-8pm ET.

Root cause

Device Design

Status

Terminated

Product code

LXH

Quantity affected

412 units

Distribution

Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, Fran

Date initiated

2014-07-23

Date posted

2014-08-14

Date terminated

2015-09-15

Location

Warsaw, IN