Recall Z-1895-2012
Zimmer, Inc. · initiated May 12, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Catalog number 47-4307-031-00; lot 62071190
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: Mixed-up of materials/components
Action taken
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.
Details
- Recall number
- Z-1895-2012
- Initiated
- May 12, 2012
- Posted by FDA
- June 27, 2012
- Terminated
- September 12, 2013
- Product code
- KWT – Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- Quantity
- 87 units
- Distribution
- Nationwide: TX, FL, MS, MI, OH, KS, TN, KY, OK, UT, CO, CA, IL, NC, NJ, ND, and WI.
- Recalling firm
- Zimmer, Inc., Warsaw, IN