Device 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.
Z-1895-2012
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 61952
- Status
- Terminated
- Classification
- Class II
- Quantity
- 87 units
- Official record key
device-enforcement:Z-1895-2012
Official wording
Reason: 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.
Code information: Catalog number 47-4307-031-00; lot 62071190
Distribution pattern: Nationwide: TX, FL, MS, MI, OH, KS, TN, KY, OK, UT, CO, CA, IL, NC, NJ, ND, and WI.
Derived failure modes
-
Unknown
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.