Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Bigliani/FlatowThe Complete Shoulder Solution Trabecular Metal Glenoid Instr Drill w/Stop

  • 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 Bigliani/FlatowThe Complete Shoulder Solution Trabecular Metal Glenoid Instr Drill w/Stopsee related information
Date Initiated by FirmMay 12, 2012
Date PostedJune 27, 2012
Recall Status1 Terminated 3 on September 12, 2013
Recall NumberZ-1895-2012
Recall Event ID 61952
510(K)NumberK103404 
Product Classification Prosthesis, shoulder, non-constrained, metal/polymer cemented - Product Code KWT
ProductBigliani/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
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
ActionZimmer 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 Commerce87 units
DistributionNationwide: TX, FL, MS, MI, OH, KS, TN, KY, OK, UT, CO, CA, IL, NC, NJ, ND, and WI.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KWT
-
-