DJO Empowr Knee Locking Tibial Punch Guide recall
DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, NON STERILE, Qty 1 For use in orthopedic surgery.
Why was DJO Empowr Knee Locking Tibial Punch Guide 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 252567
- Product
- DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, 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)