• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Metha(R) Hip System Cobalt Chrome (CoCr) Metha Modular Neck Adapters used with the Metha Modular Sho

  • 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 Metha(R) Hip System Cobalt Chrome (CoCr) Metha Modular Neck Adapters used with the Metha Modular Sho see related information
Date Initiated by Firm July 19, 2011
Date Posted August 12, 2011
Recall Status1 Terminated 3 on March 19, 2013
Recall Number Z-3014-2011
Recall Event ID 59463
510(K)Number K071916  
Product Classification Prosthesis, Hip, Semi-constrained, - Product Code LZO
Product Metha(R) Hip System Cobalt Chrome (CoCr) Metha Modular Neck Adapters used with the Metha Modular Short Hip Stems.
Aesculap AG.

Intended to replace a hip joint
Code Information Part Numbers: NC077K, NC078K, NC079K, NC087K, NC088K, NC089K, NC097K, NC098K, and NC099K)  Lot Numbers: All distributed lot numbers.
Recalling Firm/
Manufacturer
Aesculap Inc
3773 Corporate Pkwy
Center Valley PA 18034-8217
For Additional Information Contact Lisa M. Boyle
800-258-1946
Manufacturer Reason
for Recall
Aesculap Implant Systems received a notification from the manufacturer, Aesculap, AG of a fractured CoCr neck adapter.
FDA Determined
Cause 2
Unknown/Undetermined by firm
Action AESCULAP Implant Systems sent an "Important Recall Notification" letter dated to all affected customers. The informed customers of a complaint received where fractured CoCR adapter was found and to return any affected product to the firm. The reason for the fracture is currently under investigation. While the firm is trying to determine the root cause of the fracture, they will be offering the Metha non-modular short hip implants to their customers. Customers are asked to return an Inventory Sheet to AESCULAP. For additional information on this recall call (610) 984-9239 or (610) 984-9300.
Quantity in Commerce 149
Distribution Nationwide (USA) Distribution including the states of AL, FL, GA, MD, NM, NY, OK, and 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 = LZO and Original Applicant = AESCULAP IMPLANT SYSTEMS, INC.
-
-