Empowr recall
EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007.
Why was Empowr recalled?
There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portion of the drill may bind within the Posterior Peg drill guide. The extended length of the drill guide and tight tolerances to ensure accurate preparation seem to be contributing to this situation. There is a potential of a delay in surgery if this issue were to recur.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
all lot numbers
- Product
- EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007.
- Recalling firm
- Encore Medical, LP
- Quantity
- 28 units
- Distribution
- US: AZ, CA, FL, GA, IL, IN, MI, MN, NY, TX, VA, and WA.. No OUS Consignees.
- Recall date
- December 2, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)