Signature TKA GDE/MDL Set 04-05 Patient-specific recall
Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.
Why was Signature TKA GDE/MDL Set 04-05 Patient-specific recalled?
A patient specific case of Signature Personalized Patient Care System Knee Guides included a femur guide which does not match the patient associated with the case. If the issue is not identified prior to surgery, the personalized patient specific guide would provide an improper fit and would not be able to be used.
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?
Lot #154970
- Product
- Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.
- Recalling firm
- Materialise USA LLC
- Quantity
- 1
- Distribution
- One consignee, Indiana.
- Recall date
- June 15, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)