Recall Z-0611-2020 ยท LXH Orthopedic Manual Surgical Instrument
Encore Medical, Lp
EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096
| Date | Dec 6, 2019 (initiated Feb 4, 2019) |
| Status | Open, Classified |
| 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 |
| Root cause | Device Design |
| Action | On February 4, 2019, DJO emailed consignees a Urgent Field Safety Notice" concerning the recalled product. This field safety notices provided consignees "best practices" for use of the device. On August 19, 2019, DJO revised their "Urgent Field Safety Notice" to communicate the exchange process for physical product in consignees inventory. The field safety notices asked consignees to take the following actions: 1. Please locate within your inventory part 800-05-035 in FA K EMP COMP PAT TOOL KIT, FA K EMP PAT TOOL KIT, and FA K EMP PAT TOOL KIT WIMPCTR. The quantities shown within each cons |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.