Z-0611-2020 Class II Ongoing
FDA device recall Z-0611-2020 was initiated by Encore Medical, Lp on Feb 4, 2019 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 410 devices.
Recall details
- Product Type
- Devices
- Report Date
- Dec 18, 2019
- Initiation Date
- Feb 4, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 410 devices
Product description
EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096
Reason for recall
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
Distribution pattern
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
Code information
All Lots
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0611-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026