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U.S. Department of Health and Human Services

Class 2 Device Recall Endo & Unipolar Femoral Heads

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  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-2547-2014
Recall Event ID 68818
510(K)Number K955473  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
Product Endo & Unipolar Femoral Heads:
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
ENDO FEMORAL HEAD 57MM DIA
ENDO FEMORAL HEAD 60MM DIA
ENDO FEMORAL HEAD 63MM DIA
ENDO FEM HEAD 41MM
ENDO FEM HEAD 42MM
ENDO FEM HEAD 43MM
ENDO PROS HEAD 44MM
ENDO FEM HEAD 45MM
ENDO FEM HEAD 46MM
ENDO FEM HEAD 47MM
ENDO FEM HEAD 48MM
ENDO FEM HEAD 49MM
ENDO FEM HEAD 50MM
ENDO FEM HEAD 51MM
ENDO FEM HEAD 52MM
ENDO FEM HEAD 53MM
ENDO FEM HEAD 54MM
ENDO FEM HEAD 55MM
ENDO FEM HEAD 57MM
ENDO FEM HEAD 60MM
ENDO FEM HEAD 63MM
UNIPOLAR COMPONENT, 41MM
UNIPOLAR COMPONENT, 42MM
UNIPOLAR COMPONENT, 43MM
UNIPOLAR COMPONENT, 44MM
UNIPOLAR COMPONENT, 45MM
UNIPOLAR COMPONENT, 46MM
UNIPOLAR COMPONENT, 47MM
UNIPOLAR COMPONENT, 48MM
UNIPOLAR COMPONENT, 49MM
UNIPOLAR COMPONENT, 50MM
UNIPOLAR COMPONENT, 51MM
UNIPOLAR COMPONENT, 52MM
UNIPOLAR COMPONENT, 53MM
UNIPOLAR COMPONENT, 54MM
UNIPOLAR COMPONENT, 55MM
UNIPOLAR COMPONENT, 56MM
UNIPOLAR COMPONENT, 57MM
UNIPOLAR COMPONENT, 58MM
UNIPOLAR COMPONENT, 59MM
UNIPOLAR COMPONENT, 60MM
Code Information Item Numbers  00781804100, 00781804200, 00781804300, 00781804400, 00781804500, 00781804600, 00781804700, 00781804800, 00781804900, 00781805000, 00781805100, 00781805200, 00781805300, 00781805400, 00781805500, 00781805700, 00781806000, 00781806300, 00902604101, 00902604201, 00902604301, 00902604401, 00902604501, 00902604601, 00902604701, 00902604801, 00902604901, 00902605001, 00902605101, 00902605201, 00902605301, 00902605401, 00902605501, 00902605701, 00902606001, 00902606301, 451000041, 451000042, 451000043, 451000044, 451000045, 451000046, 451000047, 451000048, 451000049, 451000050, 451000051, 451000052, 451000053, 451000054, 451000055, 451000056, 451000057, 451000058, 451000059, 451000060 EXPIRATION DATE PRIOR TO 2024-01
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.
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