Total Knee Replacement recall: Labeling Error
Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/ Intended…
Why was Total Knee Replacement recalled?
Implant kit mislabeled
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?
Serial numbers: 0398482 & 0399917 Expiration Date: 12/31/2017
- Product
- Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/ Intended…
- Recalling firm
- ConforMIS, Inc.
- Quantity
- 2 units
- Distribution
- US Distribution to the states of :CA and TX.
- Recall date
- February 21, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)