Class 2 Device Recall In Situ Bender Cutter Kit Narrow Sterile

• Date Initiated by Firm: April 03, 2009
• Date Posted: May 21, 2009
• Recall Status: Terminated on September 15, 2010
• Recall Number: Z-1641-2009
• Recall Event ID: 51702
• 510(K)Number: K021458
• Product Classification: Bone Fixation Plate - Product Code HRS
• Product: In Situ Bender Cutter Kit Narrow Sterile, Catalog number 530.522S. Used with Synthes' Rapid Resorbable Fixation System which is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in adults and children.
• Code Information: Lot numbers: TM00051 exp 9/24/02, TM00072 exp 03, TM00098 exp 1/31/05, TM00151 exp 10/31/05, TM00156 exp 3/9/07, TM00161 exp 12/29/07, TM00173 exp 3/30/08, TM00192 exp 5/30/08, TM00340 exp 1/3/11, TM00261 exp 3/10/09, TM00280 exp 7/31/09, TM00300 exp 10/10/09, TM00316 exp 2/27/10, TM00324 exp 4/8/10, and 4691525 exp 1/31/05.
• Recalling Firm/ Manufacturer: Synthes Spine; 1302 Wrights Ln E; West Chester PA 19380-3417
• For Additional Information Contact: Ed Hung; 610-719-5865
• Manufacturer Reason for Recall: Sterility may be compromised due to a ineffective package design.
• FDA Determined Cause: Package design/selection
• Action: 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.
• Quantity in Commerce: 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, SD, TN, TX, UT, VA, VT, WA, WI, and WV and the country of Canada.
• 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.

• 510(K) Database: 510(K)s with Product Code = HRS