Signature TKA GDE/MDL Set 04-05 recall
Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended to be used as part of the Signature…
Why was Signature TKA GDE/MDL Set 04-05 recalled?
Images belonging to a different patient were used for the production of the patient specific surgical guide. The incorrect guide may cause a delay in surgery to accommodate the preparation and use of traditional instrumentation.
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# 124471
- Product
- Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended to be used as part of the Signature…
- Recalling firm
- Materialise N.V.
- Quantity
- 1 unit
- Distribution
- Worldwide Distribution to the Netherlands only.
- Recall date
- March 25, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)