| Class 2 Device Recall Bigliani/FlatowThe Complete Shoulder Solution Trabecular Metal Glenoid Instr Drill w/Stop | |
Date Initiated by Firm | May 12, 2012 |
Date Posted | June 27, 2012 |
Recall Status1 |
Terminated 3 on September 12, 2013 |
Recall Number | Z-1895-2012 |
Recall Event ID |
61952 |
510(K)Number | K103404 |
Product Classification |
Prosthesis, shoulder, non-constrained, metal/polymer cemented - Product Code KWT
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Product | Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm; the products are medical instruments intended for use when performing surgery of the shoulder. |
Code Information |
Catalog number 47-4307-031-00; lot 62071190 |
Recalling Firm/ Manufacturer |
Zimmer, Inc. 345 E Main St Warsaw IN 46580-2746
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For Additional Information Contact | 574-372-4807 |
Manufacturer Reason for Recall | Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm. Catalog number 47-4301-031-00 was actually packaged and labeled as catalog number 47-4307-031-00, lot 62071190. |
FDA Determined Cause 2 | Mixed-up of materials/components |
Action | Zimmer sent URGENT DEVICE REMOVAL NOTIFICATION emails to distributors on May 12, 2012 to remove the product from all locations in their territories. This was an initial notification to prevent further distribution and use of the product. Zimmer Inc. sent follow-up notifications dated June 7, 2012 to the distributors, surgeons and hospital user accounts describing the product issue and providing recommended actions. Customers were directed to (877) 946-2761 for assistance or questions. |
Quantity in Commerce | 87 units |
Distribution | Nationwide: TX, FL, MS, MI, OH, KS, TN, KY, OK, UT, CO, CA, IL, NC, NJ, ND, and WI. |
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 = KWT
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