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 Sterilesee related information
Date Initiated by FirmMay 02, 2016
Date PostedJune 07, 2016
Recall Status1 Terminated 3 on December 09, 2016
Recall NumberZ-1920-2016
Recall Event ID 74053
510(K)NumberK030069 K062789 
Product Classification Plate, bone - Product Code JEY
Product1.5 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 ContactAnne 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
ActionDePuy 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 Commerce14 units
DistributionNationwide Distribution to DE, NC, CA, OK, PA, SC, WI, CO, NJ, TX, UT, IL, MO, MI, AL, KS.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JEY
-
-