Lower riskMedical device recall · FDA · Published December 22, 2022
Encore Medical Knee Implant Labels May Cause Surgical Delay - Recall
Encore Medical recalls knee tibial inserts with incorrect size labeling that could lead to surgical delays or wrong pin sizes during surgery. Affected products include specific sizes and reference numbers.
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.
“Encore Medical Knee Implant Labels May Cause Surgical Delay - Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59073-encore-medical-knee-implant-labels-may-cause-surgical-delay-recall. Based on FDA recall #Z-1187-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1187-2023%22&limit=1).
The FDA announced on Dec. 22, 2022, that Encore Medical, LP is recalling EMPOWR VVC knee tibial inserts due to incorrect labeling of box sizes. This error could lead to surgical delays or the implantation of incorrect pin sizes. Owners should contact the company for a remedy.
Lot Codes: 484V1013 through 484V1018; 485V1001 through 485V1004; 486V1005 through 486V1008; 487V1001 through 487V1004; 488V1003 through 488V1006; 489V1003 through 489V1006; 490V1001 through 490V1004; 491V1002 through 491V1004; 492V1002 through 492V1005; 493V1001 through 493V1004; 494V1001 through 494V1004; 495V1001 through 495V1004; 502V1001 through 502V1003; 503V1003 through 503V1007
Distribution: US states of MN, IL, IN, NY, FL
The hazard
According to the FDA, tibial insert implant large boxes were labeled small and 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.
Context
GovInfoNow's records show Encore Medical, LP has 43 other recalls on record since 2017-05-31. Other recent recalls of similar products include EMPOWR 3D Knee Ins 11L 14MM VE Product Mix-Up Recall (2026-02-16), Encore Medical RSP Humeral Socket Insert Recall (2026-01-15), and Encore Medical EMPOWR Acetabular System Recall (2026-01-05).
How to tell if you have this one
Check for the product names and reference numbers listed in the recall: EMPOWR VVC KNEE TIBIAL INSERT, sizes 2-11, with reference numbers like 346-22-706 to 346-25-766. The specific lot numbers and UDI-DI codes are also listed in the recall.
Brand
Encore Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Labels
Look for the reference numbers and size labels on the product to confirm if it matches the recalled items.
Where it went and when
Where it was distributed
Distributed in 5 states.
Listed by the agency
Not listed
FDA distribution: “US: MN, IL, IN, NY, FL” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida, Illinois, Indiana, Minnesota, New York.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The recall states that incorrect labeling could lead to surgical delays or wrong pin sizes, but there is no mention of serious injury risks. The danger level is low_risk.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1187-2023 (December 22, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1187-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.