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Recall Observatory FDA recall evidence

Device product

DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980

Z-2103-2021

May 12, 2021

Class II

Product summary

Firm
Encore Medical, LP
Event
Event 87942
Status
Ongoing
Classification
Class II
Quantity
10 units
Official record key
device-enforcement:Z-2103-2021

Official wording

Reason: 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.

Code information: Lot # 115T1035

Distribution pattern: US: Nationwide Distribution in the states of VA, MN, TX, IL, MS, CA, KS, LA, and GA OUS: None

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.