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U.S. Department of Health and Human Services

Class 2 Device Recall EMPOWR Porous Knee Patella Over Drill; EMPOWR Knee Patella Drill

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  Class 2 Device Recall EMPOWR Porous Knee Patella Over Drill; EMPOWR Knee Patella Drill see related information
Date Initiated by Firm February 28, 2023
Date Posted April 12, 2023
Recall Status1 Open3, Classified
Recall Number Z-1384-2023
Recall Event ID 91906
510(K)Number K212941  
Product Classification Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer - Product Code MBH
Product EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108
Code Information REF/UDI-DI/Lot: 802-05-104/00190446238843/388620L01; 802-05-108/00190446365907/388620L03
Recalling Firm/
Manufacturer		 Encore Medical, LP
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information Contact
512-834-6200
Manufacturer Reason
for Recall		 Patella drills are marked with incorrect diameter size of 5.6mm, when they should be 5.4mm. Porous patella overdrills are marked with incorrect diameter size of 5.4 mm, when they should be 5.6 mm. If the incorrect drill is selected during surgery, there is risk of the implant loosening, implant not properly fitting, and/or fractured bone.
FDA Determined
Cause 2		 Process change control
Action On 2/28/23, field safety notices were emailed to surgical sales agents who were asked to document the quantity of affected devices complete and return the acknowledgement form. Customer service contact, customerservice@enovis.com, was provided to report failures or to request replacements. Customers with questions can phone (914) 450-3931, or email livia.kuruvila@enovis.com.
Quantity in Commerce 29
Distribution US: TX, IN, MD, CA, KS, AL, HI, WA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MBH and Original Applicant = Encore Medical, L.P. dba DJO Surgical
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