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Empowr Vvc Knee Tibial Insert, Size 6, 22mm, Ref: 346-22-706 recallZ-1187-2023 · Encore Medical, LP · initiated Dec 22, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Encore Medical, LP or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Labeling Change Control

What the company is doing

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.

Recall details

Recall number
Z-1187-2023
Status
Open, Classified
Initiated by the company
Dec 22, 2022
Posted by the FDA
Feb 27, 2023
Recalling firm
Encore Medical, LP
Quantity
216
Product code
JWH
FDA submissions
K180930
Distribution
US: MN, IL, IN, NY, FL

Product description

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 (models, lots, serial numbers)

Show the full code information (1k characters)

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;

Devices named in this recall

14 devices in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

54 devices cleared under K180930 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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