EMPOWR Locking Femoral Impactor recall
EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096
Why was EMPOWR Locking Femoral Impactor recalled?
The firm has received reports/complaints concerning the breakage of the tips of the locking femoral Impactor. Additionally, if the impactor is not seated correctly on the implant prior to impaction, this may cause off axis loading which can increase the risk of device failure. This could cause a delay in surgery. If the tip is not seen during surgery, long term risks may include an inflammatory response, infection, and/ or pain
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 Lots
- Product
- EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096
- Recalling firm
- Encore Medical, Lp
- Quantity
- 410 devices
- Distribution
- CO, WA, CA, UT, CA, TN, TX, MS, MO, AR, OK, LA, MN, IL, IN, KY, OH, MI, PA, SC, FL, PR, AL, GA, NM, AZ, NV, VA, RI, MD, ME PA, NY OUS: None
- Recall date
- December 18, 2019
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)