CLASS II ONGOING Device recall · Reported 1 Jan 2025 · FDA Enforcement Report
Empowr 3D Knee Tibial Insert, 5R, VE recalled by Encore Medical
Encore Medical is recalling Empowr 3D Knee Tibial Insert, 5R, VE, distributed nationwide in the US. The recall was initiated on 18 Dec 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0766-2025
- FDA event ID
- 96019
- Recalling firm
- Encore Medical, Austin, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Dec 2024
- FDA classified
- 26 Dec 2024
- Reported
- 1 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Hip & Knee Implants
Timeline
| 18 Dec 2024 | Recall initiated by company | |
| 26 Dec 2024 | Classified by FDA | +8 days |
| 1 Jan 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703
Where it was distributed
US Nationwide distribution in the states of VA, MN, TX, WI, IA, IL, IN, SC, NY, MD, CA, FL, AZ, WA.
Nationwide ArizonaCaliforniaFloridaIowaIllinoisIndianaMarylandMinnesotaNew YorkSouth CarolinaTexasVirginiaWashingtonWisconsin
Questions about this recall
Why was it recalled?
5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product.
Which lots are affected?
REF/UDI-DI/Lot: 342-16-705/00888912167628/159T1086 342-14-703/00888912167505/137T1086
Where was it sold?
US Nationwide distribution in the states of VA, MN, TX, WI, IA, IL, IN, SC, NY, MD, CA, FL, AZ, WA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Encore Medical
All 99| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Empowr 3d Knee Ins, Ve recalled by Encore Medical | Encore Medical | Packaging Defects | 14 states |
| Device | CLASS II | Empowr 3d Knee Ins, Ve recalled by Encore Medical | Encore Medical | Packaging Defects | 14 states |
| Device | CLASS II | Empowr 3d Knee Ins, Ve recalled by Encore Medical | Encore Medical | Labeling Errors | Nationwide |
| Device | CLASS II | Reverse Shoulder Prosthesis recalled by Encore Medical | Encore Medical | Labeling Errors | Nationwide |
| Device | CLASS II | Reverse Shoulder Prosthesis recalled by Encore Medical | Encore Medical | Labeling Errors | Nationwide |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |