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U.S. Department of Health and Human Services

Class 2 Device Recall Bigliani/Flatow The Complete Shoulder Solution

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  Class 2 Device Recall Bigliani/Flatow The Complete Shoulder Solution see related information
Date Initiated by Firm June 11, 2013
Date Posted July 10, 2013
Recall Status1 Terminated 3 on January 30, 2014
Recall Number Z-1676-2013
Recall Event ID 65290
510(K)Number K110791  
Product Classification Prosthesis, shoulder, hemi-, humeral, metallic uncemented - Product Code HSD
Product Bigliani/Flatow¿ The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm

This reusable trial device is used in orthopaedic joint replacement and is specific to the replaced joint (e.g. hip, knee, shoulder, ankle, elbow). It can be made of metal or plastic.
Code Information Item 00-4301-012-17; lot 62283991
Recalling Firm/
Manufacturer		 Zimmer, Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
877-946-2761
Manufacturer Reason
for Recall		 The firm is initiating a removal of one lot of the Bigliani/Flatow Humeral Provisional Stem (00-4301-012-17, lot 62283991) as the stems manufactured under the lot are 14mm x 170mm devices incorrectly etched and packaged as 12mm x 170mm devices.
FDA Determined
Cause 2		 Packaging process control
Action Zimmer sent an URGENT MEDICAL DEVICE RECALL notification dated June 11, 2013, to all consignees via email and courier describing the affected device and problem and the risks associated with using the affected device. The notifications provided instructions for returning the affected device to Zimmer Product Service Department, 1777 West Center Street, Warsaw, IN 46580. Any questions or concerns concerning the recall, please call the customer call center at 1-877-946-2761. Customers may report adverse events or quality problems experienced with the use of these products to Zimmer by email at zimmer.per@zimmer.com. For questions regarding this recall call 800-613-6131.
Quantity in Commerce 1
Distribution Nationwide Distribution including IL and MO.
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 = HSD and Original Applicant = ZIMMER, INC.
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