| Class 2 Device Recall Anatomical Shoulder" Inverse/Reverse Humeral PEInsert | |
Date Initiated by Firm | September 04, 2012 |
Date Posted | November 06, 2012 |
Recall Status1 |
Terminated 3 on April 16, 2014 |
Recall Number | Z-0231-2013 |
Recall Event ID |
63103 |
510(K)Number | K053274 |
Product Classification |
Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
|
Product | Anatomical Shoulder" Inverse/Reverse Humeral PE-Insert
Sterile, Rx |
Code Information |
REF Numbers: 01.04223.360, 01.04223.366, 01.04223.400, 01.04223.403, and 01.04223.406 Lot:2330423, 2337486, 2503675, 2335914, 2324383, 2395586, 2405596, 2465511, 2309008, 2309008, 2309008, 2446964. |
Recalling Firm/ Manufacturer |
Zimmer, Inc. 345 E Main St Warsaw IN 46580-2746
|
For Additional Information Contact | 574-372-4807 |
Manufacturer Reason for Recall | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info |
FDA Determined Cause 2 | Error in labeling |
Action | Zimmer, Inc. sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated September 4, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Certificate of Acknowledgement Form was attached for customers to complete and return via fax to Zimmer, Inc. at 574 372-4265. |
Quantity in Commerce | 74 |
Distribution | Nationwide 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 = KWS
|
|
|
|