Bigliani/Flatow¿ The Complete Shoulder Solution recall
Bigliani/Flatow¿ The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm This reusable trial device is used in orthopaedic joint…
Why was Bigliani/Flatow¿ The Complete Shoulder Solution 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Item 00-4301-012-17; lot 62283991
- Product
- Bigliani/Flatow¿ The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm This reusable trial device is used in orthopaedic joint…
- Recalling firm
- Zimmer, Inc.
- Quantity
- 1
- Distribution
- Nationwide Distribution including IL and MO.
- Recall date
- July 17, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)