The TM Ardis Interbody System Inserter Stainless Steel recall
The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx only. The TM Ardis Inserter is intended for delivery of the TM…
Why was The TM Ardis Interbody System Inserter Stainless Steel recalled?
Zimmer Spine is has received complaints of difficulty in turning the implant release knob of the TM Ardis Inserter after final positioning of the TM Ardis interbody spacer implant. There has been two reports where the inserter instrument was inadvertently removed from patient with the implant still engaged. The correction includes revised directions explaining the technique to remove the implant
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?
Part number: 96-701-10001; Lot numbers: 61946711, 61946712, 61991588, 62000412,
- Product
- The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx only. The TM Ardis Inserter is intended for delivery of the TM…
- Recalling firm
- Zimmer, Inc.
- Quantity
- 170
- Distribution
- USA nationwide; Europe, Sweden
- Recall date
- January 16, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)