Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Malleable C Retractor

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Malleable C Retractor see related information
Date Initiated by Firm December 15, 2014
Date Posted January 14, 2015
Recall Status1 Terminated 3 on August 18, 2016
Recall Number Z-0973-2015
Recall Event ID 70018
Product Classification Retractor - Product Code GAD
Product Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft tissues during use of trocar instrumentation. Used in the following systems: the Basic Trocar System, Universal Trocar System, Craniofacial Modular Fixation System, Craniofacial (CMF) Distraction System, MatrixORTHOGNATHIC Plating System, and the Matrix MANDIBLE Plating System.
Code Information Part Number 397.232, Lot Numbers  1698700 4688882 4868698 5129449 5345722 6009689 6235842 6407718 1702300 4688883 4916060 5129450 5356127 6021041 6241331 6407719 1715800 4772507 4916061 5129453 5382066 6023019 6258401 6446480 175220 4772508 4916062 5247085 5422622 6023020 6258402 6446481 1685602 4814278 4991953 5247087 5664372 6040195 6300954 6452871 1695100 4814280 4991962 5263641 5664373 6040196 6321761 6452872 1695101 4814281 4992455 5267067 5685461 6056610 6345256 6623687 1706600 4868678 5032047 5267068 5820702 6097962 6345257 6633304 1776300 4868685 5080386 5287150 5839165 6181398 6355110  1798900 4868691 5080387 5287152 5855648 6212655 6407717   
Recalling Firm/
Manufacturer		 Synthes, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Customer Support
610-719-5000
Manufacturer Reason
for Recall		 Potential failure and/or corrosion of the internal spring of the retractor, which may have been manufactured from an incorrect material. Surgical delay may occur. Spring particles could transfer from the instrument to the patient, and may lead to an adverse tissue reaction and/or infection.
FDA Determined
Cause 2		 Component design/selection
Action The firm, DePuy Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated December 15, 2014, to its end users and sales consultants. The letter identified the product, problem, and actions to be taken. The End users/sales staff were instructed to immediately remove affected stock from inventory; call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number; complete and return the attached Verification Section to DePuy Synthes via fax: 866-827-3421 or Scan/email: Synthes8645@stericycly.com, even if you do not have any of the affected product, and return any affected devices to Synthes. If you have any questions, please call 610-719-5450 or contact your DePuy Synthes sales consultant.
Quantity in Commerce 1762
Distribution Worldwide Distribution: US (nationwide) and internationally to 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.
-
-