In Situ Bender Cutter Kit Wide Sterile, Catalog number 530.521S Used with Synthes' Rapid Resorbable Fixation System whic

FDA device recall Z-1640-2009 · posted 2009-05-21 · Terminated

Recall details

Recalling firm

Synthes Spine

Reason for recall

Sterility may be compromised due to a ineffective package design.

Action taken

All affected Synthes DMF Sales Consultants were notified of the Medical Device Recall by an Urgent: Medical Device Recall letter notification which was sent via USPS certified mail on 4/6/09. The letter stated the problem and risk. The firm recommended that patients who have had a surgical procedure in which these products were utilized be monitored for signs/symptoms of infection for a period of six months following surgery. If customers have any of the identified devices, they are to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number; complete the form; and return the letter with the recalled product to the address provided. Customers that do not have the identified product, are to complete the attached form and return the document to the address provided acknowledging their receipt of the recall information. Questions should be directed to their Synthes CMF Sales Consultant.

Root cause

Package design/selection

Status

Terminated

Product code

HRS

Quantity affected

2706 units total

Distribution

Worldwide Distribution -- USA including states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC

Date initiated

2009-04-03

Date posted

2009-05-21

Date terminated

2010-09-15

Location

West Chester, PA

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