Omnilife Science

Code	Device name	Class	Specialty	Clearances	Most recent
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Class II	Orthopedic	1	2021-04-02

Date	Severity	Status	Recall #	Product	Code	Reason
2021-10-01	Class II	Terminated	Z-0237-2022	OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component …	—	The device is missing grit blasting on the proximal surface of the femoral stem, which may lead to the possibility of product revision in the event of undersizi…
2020-12-21	Class II	Terminated	Z-0922-2021	SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for…	—	Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a re…
2020-12-21	Class II	Terminated	Z-0921-2021	SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup fo…	—	Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a re…
2020-12-21	Class II	Terminated	Z-0920-2021	SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup fo…	—	Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a re…

Date	K-number	Device	Code	Class	Specialty
2021-04-02	K201611	Apex Knee System	JWH	Class II	Orthopedic

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