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.
FDA Recall Z-1895-2012 · Posted 2012-06-27
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Recalling FirmZimmer, Inc.
Recall StatusTerminated
Product CodeKWT
Date Initiated2012-05-12
Date Terminated2013-09-12
Product Quantity87 units
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.
Firm 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.
Root Cause
Mixed-up of materials/components
Distribution Pattern
Nationwide: TX, FL, MS, MI, OH, KS, TN, KY, OK, UT, CO, CA, IL, NC, NJ, ND, and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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