—#109571

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.

FDA product code: KWT — Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K103404
Affected lot / code info: Catalog number 47-4307-031-00; lot 62071190

Why it was recalled

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.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

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.

Recalling firm

Firm: Zimmer, Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: Nationwide: TX, FL, MS, MI, OH, KS, TN, KY, OK, UT, CO, CA, IL, NC, NJ, ND, and WI.

Timeline

Recall initiated: 2012-05-12
Posted by FDA: 2012-06-27
Terminated: 2013-09-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #109571. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.