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

  • 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 see related information
Date Initiated by Firm June 05, 2009
Date Posted May 20, 2010
Recall Status1 Terminated 3 on October 22, 2013
Recall Number Z-1625-2010
Recall Event ID 52527
510(K)Number K960425  K904870  K842234  
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System.

BP Ankle System, F-P Type III Ankle Bearing Component:
2x5mm F-P Type III Ankle Bearing Catalog: 05-13-0532,
2x7mm F-P Type III Ankle Bearing Catalog: 05-13-0732,
8x3mm F-P Type III Ankle Bearing Catalog: 05-13-0533,
8x1mm F-P Type III Ankle Bearing Catalog: 05-13-0731.

BP Ankle System, F-P Type III Tibial Ankle Component:
Size 1 F-P Type III Tibial Component Catalog: 05-12-0031,
Size 2 F-P Type III Tibial Component Catalog: 05-12-0032,
Size 3 F-P Type III Tibial Component Catalog: 05-12-0033.

BP Ankle System, F-P Type III Talar Component:
Size 1 F-P Type III Talar Component Catalog: 05-01-0031,
Size 2 F-P Type III Talar Component Catalog: 05-01-0032,
Size 3 F-P Type III Talar Component Catalog: 05-01-0033.
Code Information Lot No: 05010031BNN376 05010032BNN376 05010033BNN376 05010033CNN376 05120031BNN376 05120032BNN377 05120033BNN376 05130532BNN377 05130732BNN377 05130533BNN376  05130731BNN376
Recalling Firm/
Manufacturer		 Endotec, Inc.
2546 Hansrob Rd
Orlando FL 32804-3318
For Additional Information Contact
407-822-0021
Manufacturer Reason
for Recall		 Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results.
FDA Determined
Cause 2		 Other
Action Recall Letters were sent to each distributor on 06/07/2009. Questions are directed to Endotec at (407) 822-0021.
Quantity in Commerce 50 Pieces
Distribution Worldwide distribution -- US in OH, TX, CA, FL, NJ, TN; and International Distribution: Korea, Australia, Switzerland, The Netherlands, Spain. Domestic: OH, TX, CA, FL, NJ, TN.
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 = JWH and Original Applicant = ENDOMEDICS, INC.
510(K)s with Product Code = JWH and Original Applicant = ENDOTEC, INC.
-
-