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Class 2 Device Recall 2.5 mm Guide Rod, with smooth tip, 950 mm, sterile |
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Date Initiated by Firm |
July 26, 2017 |
Create Date |
March 05, 2018 |
Recall Status1 |
Terminated 3 on September 10, 2018 |
Recall Number |
Z-0905-2018 |
Recall Event ID |
79157 |
Product Classification |
Reamer - Product Code HTO
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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
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For Additional Information Contact |
Anne Brisson 610-719-5443
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Manufacturer Reason for Recall |
Possible lack of product sterility due to potential gaps/channeling in the seal of the package.
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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 |
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
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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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