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 Endo & Unipolar Femoral Heads

  • 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 Endo & Unipolar Femoral Heads see related information
Date Initiated by Firm July 22, 2014
Date Posted August 26, 2014
Recall Status1 Terminated 3 on September 15, 2015
Recall Number Z-2548-2014
Recall Event ID 68818
510(K)Number K960278  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
Product Endo & Unipolar Femoral Heads:
ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD 53MM DIA, ENDO FEMORAL HEAD 47MM DIA, ENDO FEMORAL HEAD 50MM DIA, ENDO FEMORAL HEAD 42MM DIA, ENDO FEMORAL HEAD 54MM DIA, ENDO FEMORAL HEAD 48MM DIA, ENDO FEMORAL HEAD 41MM DIA, ENDO FEMORAL HEAD 42MM DIA, ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD 44MM DIA, ENDO FEMORAL HEAD 45MM DIA, ENDO FEMORAL HEAD 46MM DIA, ENDO FEMORAL HEAD 47MM DIA, ENDO FEMORAL HEAD 48MM DIA, ENDO FEMORAL HEAD 49MM DIA, ENDO FEMORAL HEAD 50MM DIA, ENDO FEMORAL HEAD 51MM DIA, ENDO FEMORAL HEAD 52MM DIA, ENDO FEMORAL HEAD 53MM DIA, ENDO FEMORAL HEAD 54MM DIA, ENDO FEMORAL HEAD 55MM DIA
Code Information Item Numbers : 00781804300, 00781805300, 00781804700, 00781805000, 00781804200, 00781805400, 00781804800, 00781804100, 00781804200, 00781804300, 00781804400, 00781804500, 00781804600, 00781804700, 00781804800, 00781804900, 00781805000, 00781805100, 00781805200, 00781805300, 00781805400, 00781805500   Lot Numbers: 37210958, 37210967, 37211180, 37211183, 37211311, 37211316, 37211320, 37211379, 37211482, 62561484, 37211643, 37211645, 37211646, 37211647, 37211653, 37211655, 37211657, 37211658, 37211661, 37211801, 37211804, 37211805, 37211806, 37211811, 37211812, 37211815, 37211817, 37211820, 37212062, 37212063, 37212065, 37212074, 37212079, 62573574, 62573576, 62576002, 62576008, 62593298, 62593302, 37212608, 37211644
Recalling Firm/
Manufacturer		 Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact
800-613-6131
Manufacturer Reason
for Recall		 Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.
FDA Determined
Cause 2		 Package design/selection
Action Zimmer sent an URGENT MEDICAL DEVICE RECALL letter dated July 2014 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Please call the Customer Call Center at 1-800-348-2759 for questions or concerns involving this notice.
Quantity in Commerce 972,125 units
Distribution Worldwide Distribution.
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 = JDI and Original Applicant = ZIMMER, INC.
-
-