Z-1187-2023Class II

Empowr Vvc Knee Tibial Insert, Size 6, 22Mm, Ref: 346-22-706; Empowr Vvc Knee Tibial Insert, Size 7, 22Mm...

Name: Z-1187-2023 Empowr Vvc Knee Tibial Insert, Size 6, 22Mm, Ref: 346-22-706; Empowr Vvc Knee Tibial Insert, Size 7, 22Mm...
Creator: Encore Medical, LP
Published: 2022-12-22
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2022-12-22 / Open, Classified / root cause: labeling and UDI

FDA source

Encore Medical, LP began a recall of 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... on 2022-12-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1187-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-22
Posted: 2023-02-27
Recalling firm: Encore Medical, LP
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
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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.
Root cause tag: labeling and UDI
FDA root cause: 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
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1187-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1187-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-02-27

Product code JWH

K180930Class IIEmpowr Vvc Tibial InsertEncore Medical L.P. / cleared 2018-07-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)