Z-1676-2013 Class II Terminated
FDA device recall Z-1676-2013 was initiated by Zimmer, Inc. on Jun 11, 2013 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Jan 30, 2014). Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 17, 2013
- Initiation Date
- Jun 11, 2013
- Termination Date
- Jan 30, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
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.
Reason for Recall
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.
Distribution Pattern
Nationwide Distribution including IL and MO.
Code Information
Item 00-4301-012-17; lot 62283991
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1676-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026