Class 2 Device Recall 2.5 mm Guide Rod, with smooth tip, 950 mm, sterile

• Date Initiated by Firm: July 26, 2017
• Create Date: March 05, 2018
• Recall Status: Terminated on September 10, 2018
• Recall Number: Z-0905-2018
• Recall Event ID: 79157
• Product Classification: Reamer - Product Code HTO
• Product: 2.5 mm Guide Rod, with smooth tip, 950 mm, sterile, Part Number: 355.042S; ; Reaming Rods are intended for guiding of reamers during orthopedic surgery.
• Code Information: Distributed 31-May-217 to 20-Jun-2017; Lot Number Manufacturing Date (M/D/YYYY) Expiration Date (YYYY-MM-DD): H354470 5/27/2017 2026-04-30
• Recalling Firm/ Manufacturer: Synthes (USA) Products LLC; 1301 Goshen Pkwy; West Chester PA 19380-5986
• For Additional Information Contact: Anne Brisson; 610-719-5443
• Manufacturer Reason for Recall: Possible lack of product sterility due to potential gaps/channeling in the seal of the package.
• FDA Determined Cause: Process control
• Action: The firm, DePuy Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated 7/26/2017 to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to do the following: If you DO have any of the identified devices and intend to re-sterilize the product (TRAUMA Products only) per the package insert, please take the following steps: ¿ Complete the Verification Section at the end of this letter by checking the appropriate box indicating affected product has been located and will be re-sterilized. Also, please indicate the number of devices found. Please include your name, title, telephone number and signature in the spaces provided. ¿ Send a copy of the completed Verification Section to Synthes by: o Fax: 844-721-3045 or o Scan/email: Synthes5735@stericycle.com Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual on page 4 of the notification. If you DO have any of the identified devices, and are returning the product for replacement, please take the following steps: ¿ Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number. ¿ Complete the Verification Section (page 4 of this letter) by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return ¿ Authorization Number. Please include your name, title, address, telephone number and signature in the spaces provided. ¿ Return the Verification Section (page 4 of this letter) with the product to: o Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. ¿ Send a copy of the completed Verification Section to Synthes by: o Fax: 844-721-3045 or o Scan/email: Synthes5735@stericycle.com Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clea
• Quantity in Commerce: 21
• Distribution: Worldwide Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, the District of Columbia, including Puerto Rico, and 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.