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Open, Classified

EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096

FDA Recall Z-0611-2020 · Posted 2019-12-06

Recalling FirmEncore Medical, Lp
Recall StatusOpen, Classified
Product CodeLXH
Date Initiated2019-02-04
Product Quantity410 devices

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

Firm 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 consignee letter is specific to the consignee. 2. Contact Customer Service to initiate a return of the product via RMA and to have the replacement impactors sent to you. 3. If you have any questions, please contact Teffany Hutto by phone at (512) 834-6255 or by email at [email protected].

Root Cause

Device Design

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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