U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Guide, surgical, instrument - Product Code FZX
원인
Certain affected parts and lots of the pull reduction devices may have been manufactured to an incorrect hardness specification which could result in intraoperative breakage.
조치
DePuy Synthes sent an Urgent Notice Urgent notice dated May 28, 2015, to all affected customers to advise them of the defect and patient risks associated with its use. Customers were instructed if they have any of the identified devices, 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 3 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 3 of this letter) with the product to:
¿ Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132.
¿ Send a copy of the completed Verification Section by:
¿ Fax: (888) 943-5206 or
¿ Scan/email: Synthes2912@stericycle.com
If you DO NOT have the identified product, please take the following steps:
¿ Complete the attached Verification Section (page 3 of this letter) by checking the appropriate box indicating
that no affected product has been located. Please include your name, title, address, telephone number and
signature in the spaces provided. This return documentation acknowledges your receipt of medical device
removal information.
¿ Return the documents by:
¿ Fax: (888) 943-5206 or
¿ Scan/email: Synthes2912@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 3 of the notification.
Customers with questions were instructed to call 610-719-5450.
For questions regarding this recall call 610-719-5000.
Worldwide Distribution-US (nationwide) and internationlly to Canada
제품 설명
Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with quick coupling is placed through the guide sleeve and plate holes to pull or push bone fragments relative to the plate. This instrument can be used for: Minor Varus-valgus adjustments (approximately 2¿ - 4¿), Translational adjustments, Stabilization of plate bone orientation during insertion of the first screws, alignment of segmental fragments and pre-drilling dense or thick cortical bone before placing a 5.0 mm locking screw.