Bigliani/Flatow The Complete Shoulder Solution Trabecular… recallZ-1895-2012 · Zimmer, Inc. · initiated May 12, 2012
Class II Terminated All recalls posted in June 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Zimmer, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Mixed-up of materials/components
What the company is doing
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.
Recall details
- Recall number
- Z-1895-2012
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 12, 2012
- Posted by the FDA
- Jun 27, 2012
- Recalling firm
- Zimmer, Inc.
- Quantity
- 87 units
- Product code
- KWT
- FDA submissions
- K103404
- Distribution
- Nationwide: TX, FL, MS, MI, OH, KS, TN, KY, OK, UT, CO, CA, IL, NC, NJ, ND, and WI.
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.
Code information (models, lots, serial numbers)
Catalog number 47-4307-031-00; lot 62071190
Other devices under the same FDA submission
4 devices cleared under K103404 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Bigliani/Flatow® 4302-52-21Zimmer, Inc. · PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Bigliani/Flatow® 4300-46-15Zimmer, Inc. · PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Bigliani/Flatow® 4300-52-18Zimmer, Inc. · PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Bigliani/Flatow® 4302-40-18Zimmer, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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