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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = HSD
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