CLASS II ONGOING Device recall · Reported 28 Jul 2021 · FDA Enforcement Report
DJO Surgical Empowr 3D Knee Tibial Insert - e-plus recalled
Encore Medical is recalling DJO Surgical Empowr 3D Knee Tibial Insert - e-plus, distributed nationwide in the US. The recall was initiated on 12 May 2021 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-2103-2021
- FDA event ID
- 87942
- Recalling firm
- Encore Medical, Austin, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 May 2021
- FDA classified
- 20 Jul 2021
- Reported
- 28 Jul 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Packaging Defects
- Device type
- Hip & Knee Implants
Timeline
| 12 May 2021 | Recall initiated by company | |
| 20 Jul 2021 | Classified by FDA | +69 days |
| 28 Jul 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis.
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
DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980
Where it was distributed
US: Nationwide Distribution in the states of VA, MN, TX, IL, MS, CA, KS, LA, and GA OUS: None
Nationwide CaliforniaGeorgiaIllinoisKansasLouisianaMinnesotaMississippiTexasVirginia
Questions about this recall
Why was it recalled?
Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis.
Which lots are affected?
Lot # 115T1035
Where was it sold?
US: Nationwide Distribution in the states of VA, MN, TX, IL, MS, CA, KS, LA, and GA OUS: None
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.
Other products in this recall event
1 other product · FDA event 87942| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | DJO Surgical Empowr 3D Knee Tibial Insert - e-plus recalled | Encore Medical | Packaging Defects | Nationwide |
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 |