P.F.C. SIGMA Revision Knee System Distal Augment recall
P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
Why was P.F.C. SIGMA Revision Knee System Distal Augment recalled?
This unit may be missing the screw/collet Assembly
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: C2KJ24, GTIN: 10603295234135
- Product
- P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
- Recalling firm
- DePuy Orthopaedics, Inc.
- Quantity
- 1
- Distribution
- The devices were not distributed in the United States. The devices were distributed to the following foreign countries: Great Britain.
- Recall date
- September 5, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)