Bigliani/Flatow The Complete Shoulder Solution, Humeral… recallZ-1676-2013 · Zimmer, Inc. · initiated Jun 11, 2013
Class II Terminated All recalls posted in July 2013
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
The firm is initiating a removal of one lot of the Bigliani/Flatow Humeral Provisional Stem (00-4301-012-17, lot 62283991) as the stems manufactured under the lot are 14mm x 170mm devices incorrectly etched and packaged as 12mm x 170mm devices.
FDA root cause category: Packaging process control
What the company is doing
Zimmer sent an URGENT MEDICAL DEVICE RECALL notification dated June 11, 2013, to all consignees via email and courier describing the affected device and problem and the risks associated with using the affected device. The notifications provided instructions for returning the affected device to Zimmer Product Service Department, 1777 West Center Street, Warsaw, IN 46580. Any questions or concerns concerning the recall, please call the customer call center at 1-877-946-2761. Customers may report adverse events or quality problems experienced with the use of these products to Zimmer by email at [email protected]. For questions regarding this recall call 800-613-6131.
Recall details
- Recall number
- Z-1676-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 11, 2013
- Posted by the FDA
- Jul 10, 2013
- Recalling firm
- Zimmer, Inc.
- Quantity
- 1
- Product code
- HSD
- FDA submissions
- K110791
- Distribution
- Nationwide Distribution including IL and MO.
Product description
Bigliani/Flatow The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm This reusable trial device is used in orthopaedic joint replacement and is specific to the replaced joint (e.g. hip, knee, shoulder, ankle, elbow). It can be made of metal or plastic.
Code information (models, lots, serial numbers)
Item 00-4301-012-17; lot 62283991
Other devices under the same FDA submission
1 device cleared under K110791 — 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® 00-4302-056-27Zimmer, Inc. · PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 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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