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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91494

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 22, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Encore Medical, LP

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1187-2023
Recall number
Z-1187-2023
Initiated
December 22, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Encore Medical, LP
Quantity
216

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label, the surgeon may implant the incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

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.

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;

Distribution pattern

US: MN, IL, IN, NY, FL