EMPOWR Porous Knee System TIBIAL PUNCH recall
EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, NON STERILE, Qty 1 For use in orthopedic surgery.
Why was EMPOWR Porous Knee System TIBIAL PUNCH recalled?
The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
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 252564
- Product
- EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, NON STERILE, Qty 1 For use in orthopedic surgery.
- Recalling firm
- Encore Medical, Lp
- Quantity
- 2 units
- Distribution
- One medical device distributor in California.
- Recall date
- January 17, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)