Z-1895-2012 Class II Terminated
FDA device recall Z-1895-2012 was initiated by Zimmer, Inc. on May 12, 2012 and is designated Class II. 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… The recall status is terminated (terminated Sep 12, 2013). Affected quantity: 87 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 4, 2012
- Initiation Date
- May 12, 2012
- Termination Date
- Sep 12, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 87 units
Product Description
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.
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.
Distribution Pattern
Nationwide: TX, FL, MS, MI, OH, KS, TN, KY, OK, UT, CO, CA, IL, NC, NJ, ND, and WI.
Code Information
Catalog number 47-4307-031-00; lot 62071190
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1895-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026