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Class 2 Device Recall EMPOWR VVC KNEE TIBIAL INSERT |
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Date Initiated by Firm |
December 22, 2022 |
Date Posted |
February 27, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1187-2023 |
Recall Event ID |
91494 |
510(K)Number |
K180930
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Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
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Product |
EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706;
EMPOWR VVC KNEE TIBIAL INSERT, SIZE 7, 22MM, REF: 346-22-707;
EMPOWR VVC KNEE TIBIAL INSERT, SIZE 8, 22MM, REF: 346-22-708;
EMPOWR VVC KNEE TIBIAL INSERT, SIZE 9, 22MM, REF: 346-22-709;
EMPOWR VVC KNEE TIBIAL INSERT, SIZE 10, 22MM, REF: 346-22-710;
EMPOWR VVC KNEE TIBIAL INSERT, SIZE 11, 22MM, REF: 346-22-711;
EMPOWR VVC KNEE TIBIAL INSERT, SIZE 5 BRIDGE UP, 22MM, REF: 346-22-755;
EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6 BRIDGE DOWN, 22MM, REF: 346-22-766;
EMPOWR VVC KNEE TIBIAL INSERT, SIZE 2, 25MM, REF: 346-25-702;
EMPOWR VVC KNEE TIBIAL INSERT, SIZE 3, 25MM, REF: 346-25-703;
EMPOWR VVC KNEE TIBIAL INSERT, SIZE 4, 25MM, REF: 346-25-704;
EMPOWR VVC KNEE TIBIAL INSERT, SIZE 5, 25MM, REF: 346-25-705;
EMPOWR VVC KNEE TIBIAL INSERT, SIZE 5 BRIDGE UP, 25MM, REF: 346-25-755;
EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6 BRIDGE DOWN, 25MM, REF: 346-25-766 |
Code Information |
REF/UDI-DI/Lot:
346-22-706/ 00190446219378/484V1013, 484V1014, 484V1015, 484V1016, 484V1017, 484V1018;
346-22-707/ 00190446219385/485V1001, 485V1002, 485V1003, 485V1004;
346-22-708/ 00190446219392/486V1005, 486V1006, 486V1007, 486V1008;
346-22-709/ 00190446219408/487V1001, 487V1002, 487V1003, 487V1004;
346-22-710/ 00190446219415/488V1003, 488V1004, 488V1005, 488V1006;
346-22-711/ 00190446219422/489V1003, 489V1004, 489V1005, 489V1006;
346-22-755/ 00190446219439/490V1001, 490V1002, 490V1003, 490V1004;
346-22-766/ 00190446219477/491V1002, 491V1003, 491V1004;
346-25-702/ 00190446219507/492V1002, 492V1003, 492V1004, 492V1005;
346-25-703/ 00190446219569/493V1001, 493V1002, 493V1003, 493V1004;
346-25-704/ 00190446219583/494V1001, 494V1002, 494V1003, 494V1004;
346-25-705/ 00190446219590/495V1001, 495V1002, 495V1003, 495V1004;
346-25-755/ 00190446219781/ 502V1001, 502V1002, 502V1003;
346-25-766/ 00190446219798/503V1003, 503V1004, 503V1005, 503V1006, 503V1007;
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Recalling Firm/ Manufacturer |
Encore Medical, LP 9800 Metric Blvd Austin TX 78758-5445
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For Additional Information Contact |
512-834-6200
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Manufacturer Reason for Recall |
Tibial insert implant large boxes were labeled small and the small boxes were labeled large. If the incorrect labeling is identified this could lead to surgical delay and if the surgeon does not recognize the size discrepancy between the insert label and the pin label, the surgeon may implant the incorrect pin size.
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FDA Determined Cause 2 |
Labeling Change Control |
Action |
On 12/22/22 recall notices were emailed to surgical agents who were asked to do the following:
1) Pass on the notice to all those within their organization or to any organization where potentially affected products have been transferred.
2) Return affected products.
3) Complete and return the Consignee Reconciliation notice.
The following number was provided: Customer Service, 1-800-456-8696
On 2/8/23 recall notices were emailed with an expanded scope. |
Quantity in Commerce |
216 |
Distribution |
US: MN, IL, IN, NY, FL |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = JWH and Original Applicant = Encore Medical, L.P.
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