DJO Surgical EMPOWR 3D Knee Insert Recall: Packaging Mixup Risk
DJO Surgical recalls EMPOWR 3D Knee Tibial Insert e-plus models with packaging mixup risk. Incorrect size knee prostheses may be shipped. Check your product label for serial number and size.
Lower-risk 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.
Contact the company
What happened, in plain English
DJO Surgical is recalling specific models of knee inserts due to a packaging mix-up. This could mean customers receive the wrong size prosthesis, which might not fit properly and cause complications during surgery. Read more at govinfonow.com/recall/62558-djo-surgical-empowr-3d-knee-insert-recall-packaging-mixup-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/62558-djo-surgical-empowr-3d-knee-insert-recall-packaging-mixup-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2103-2021
Cite this page
“DJO Surgical EMPOWR 3D Knee Insert Recall: Packaging Mixup Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62558-djo-surgical-empowr-3d-knee-insert-recall-packaging-mixup-risk. Based on FDA recall #Z-2103-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2103-2021%22&limit=1).
Why it’s dangerous
The packaging mix-up means that 12mm knee prosthesis packaging might contain 16mm prosthesis and vice versa. Using the wrong size could lead to improper fit during surgery, potentially causing complications.
Who’s affected
Patients scheduled for knee surgery using the recalled EMPO: 341-12-711, Left Size 11, 12mm models. Surgeons and medical staff handling these implants are most at risk.
How to tell if you have this one
Check your product label for the serial number (01)00888912166980 and lot number 115T1035. The product is a left knee insert size 11 with 12mm dimensions.
- Brand
DJO Surgical- Product
DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US: Nationwide Distribution in the states of VA, MN, TX, IL, MS, CA, KS, LA, and GA OUS: None
| Recall number | Product, codes & lots |
|---|---|
| Z-2103-2021 | DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980; Lot # 115T1035 |
| Z-2104-2021 | DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185; Lot # 155T1035 |
What to do — step by step
Check Product Label
Look for the serial number (01)00888912166980 and lot number 115T1035 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 9 states.
FDA distribution: “US: Nationwide Distribution in the states of VA, MN, TX, IL, MS, CA, KS, LA, and GA OUS: None” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Georgia, Illinois, Kansas, Louisiana, Minnesota, Mississippi, Texas, Virginia.
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-2103-2021 (May 12, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2103-2021 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.