Z-2659-2017 Class II Terminated
FDA device recall Z-2659-2017 was initiated by Encore Medical, Lp on May 31, 2017 and is designated Class II. Reason for recall: Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert. The recall status is terminated (terminated Jan 8, 2021). Affected quantity: 9 units.
Recall details
- Product Type
- Devices
- Report Date
- Jul 12, 2017
- Initiation Date
- May 31, 2017
- Termination Date
- Jan 8, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 units
Product description
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.
Reason for recall
Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert.
Distribution pattern
Worldwide Distribution-US (nationwide) to states of: AL, TX, UT, and CA; and countries of: INDIA and GERMANY.
Code information
Lot # 339G1045
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2659-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026