# FDA recall Z-2658-2017

> **Encore Medical, Lp** · Class II · device recall initiated 2017-05-31.

## Product

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.

## Reason for recall

Mis-pack.  A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert.

## Distribution

Worldwide Distribution-US (nationwide) to states of: AL, TX, UT, and CA; and countries of:  INDIA and GERMANY.

## Key facts

- **Recall number:** Z-2658-2017
- **Recalling firm:** Encore Medical, Lp
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-05-31
- **Report date:** 2017-07-12
- **Termination date:** 2021-01-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Austin, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2658-2017

## Citation

> AI Analytics. FDA recall Z-2658-2017. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2658-2017. Source: US FDA. Licensed CC0.

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