Genesis(r) II Cruciate Retaining Articular Insert recall
GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 71430490, Product Usage: Orthopedic
Why was Genesis(r) II Cruciate Retaining Articular Insert recalled?
The products were produced using the wrong color material, resulting in the devices being red (used for deep dished inserts) instead of blue (used for cruciate retaining inserts).
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 Number 12LM03798
- Product
- GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 71430490, Product Usage: Orthopedic
- Recalling firm
- Smith & Nephew Inc
- Quantity
- 9 units
- Distribution
- International only: Germany, France, United Arab Emirates, and United Kingdom.
- Recall date
- August 28, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)