Recall Z-0611-2020— Encore Medical, Lp
Class II · Ongoing
Class II FDA medical device recall by Encore Medical, Lp, initiated 2019-02-04. FDA's recall record names no specific 510(k) clearance for this event. Product: EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096. Reason: 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.
- Recalling firm
- Encore Medical, Lp
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-02-04
- Firm location
- Austin, TX, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.