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 1.5 mm RAPIDSORB Rapid Resorbable Orbital Floor Plates with Bending Template Sterile

  • 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 1.5 mm RAPIDSORB Rapid Resorbable Orbital Floor Plates with Bending Template Sterile see related information
Date Initiated by Firm May 02, 2016
Date Posted June 07, 2016
Recall Status1 Terminated 3 on December 09, 2016
Recall Number Z-1920-2016
Recall Event ID 74053
510(K)Number K062789  K030069  
Product Classification Plate, bone - Product Code JEY
Product 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template.
Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.
Code Information Catalog # 851.691.01S, Lot # 6123191, 6913455, 7540885
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		 Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.
FDA Determined
Cause 2		 Under Investigation by firm
Action DePuy Synthes sent an Urgent Medical Device Recall Notice dated May 2, 2016, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory immediately and remove the affected lots from their stock. Customers were instructed to call 1-800-479-6329 to obtain a Return Authorization (RA) Number and replacement product., customers were also asked to complete the Verification Section and scan/email to Synthes4096@stericycle.com. Customers with questions were instructed to call 610-719-5450.
Quantity in Commerce 14 units
Distribution Nationwide Distribution to DE, NC, CA, OK, PA, SC, WI, CO, NJ, TX, UT, IL, MO, MI, AL, KS.
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.
510(K) Database 510(K)s with Product Code = JEY and Original Applicant = SYNTHES (USA)
-
-