Encore Medical 3DKNEE System e+ Left Size 6 Tibial Insert Mispacked
Encore Medical recalls 3DKNEE System e+ Left Size 6 Tibial Insert (REF 391-11-706) due to mispacking: a Size 6 box contains a Size 8 insert. This affects patients using knee implants.
Lower-risk recall
Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert.
Contact the company
What happened, in plain English
Encore Medical is recalling a specific left knee insert model because it was shipped with the wrong size. Using this incorrect insert could lead to improper knee function and potential complications during surgery or recovery. Read more at govinfonow.com/recall/73995-encore-medical-3dknee-system-e-left-size-6-tibial-insert.
Source Summary by GovInfoNow · govinfonow.com/recall/73995-encore-medical-3dknee-system-e-left-size-6-tibial-insert · Updated September 23, 2026 · FDA enforcement record: FDA #Z-2658-2017
Cite this page
“Encore Medical 3DKNEE System e+ Left Size 6 Tibial Insert Mispacked.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73995-encore-medical-3dknee-system-e-left-size-6-tibial-insert. Based on FDA recall #Z-2658-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2658-2017%22&limit=1).
Why it’s dangerous
The insert was mispacked: a Size 6 box contains a Size 8 insert. This mismatch could cause improper knee alignment during surgery or recovery, potentially leading to complications. However, the hazard is not life-threatening in normal use.
Who’s affected
Patients with the specific left knee insert model (Size 6) who received a Size 8 insert instead. Those with the correct size are not affected.
How to tell if you have this one
Check if your 3DKNEE System e+ left knee insert has the model number REF 391-11-706 and was sold with Lot # 292G1910. The affected item is a Size 6 box containing a Size 8 insert.
- Brand
Encore Medical- 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
Terminated- Distribution
Worldwide Distribution-US (nationwide) to states of: AL, TX, UT, and CA; and countries of: INDIA and GERMANY.
| Recall number | Product, codes & lots |
|---|---|
| Z-2658-2017 | 3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01, The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.; Lot # 292G1910 |
| Z-2659-2017 | 3DKNEE(TM) SYSTEM e+, Tibial Insert, RIGHT Sz 8 / 11mm, REF 391-11-708, QTY 01 The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.; Lot # 339G1045 |
What to do — step by step
Check Insert Size
Verify if your left knee insert box contains a Size 8 insert instead of Size 6.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 4 states.
FDA distribution: “Worldwide Distribution-US (nationwide) to states of: AL, TX, UT, and CA; and countries of: INDIA and GERMANY.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Texas, Utah.
Recall timeline
FDA terminated this recall 3.6 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have the wrong size?
Contact Encore Medical directly to confirm the correct size and get guidance on next steps.
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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-2658-2017 (May 31, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2658-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.