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U.S. Department of Health and Human Services

Class 2 Device Recall 3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile

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  Class 2 Device Recall 3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile see related information
Date Initiated by Firm July 26, 2017
Create Date March 05, 2018
Recall Status1 Terminated 3 on September 10, 2018
Recall Number Z-0904-2018
Recall Event ID 79157
Product Classification Reamer - Product Code HTO
Product 3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number: 351.76S

Reaming Rods are intended for guiding of reamers during orthopedic surgery.
Code Information Distributed 25-Apr-2017 to 22-Jun-2017; Lot Number Manufacturing Date (M/D/YYYY) Expiration Date (YYYY-MM-DD): H306632 4/3/2017 2026-02-28 H311229 4/16/2017 2026-03-31 H311228 4/28/2017 2026-03-31 H311231 4/28/2017 2026-03-31 H319172 4/28/2017 2026-03-31 H319175 4/28/2017 2026-03-31 H318789 5/4/2017 2026-03-31 H319171 5/4/2017 2026-03-31 H327068 5/4/2017 2026-03-31 H311226 5/6/2017 2026-03-31 H311225 5/11/2017 2026-04-30 H311224 5/12/2017 2026-04-30 H327067 5/12/2017 2026-04-30 H327066 5/18/2017 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 2
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 960
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.
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