Devices

Device Recall Total Hip Joint Replacement

Model / Serial
K994366 6021-0335 6021-0537 Accolade TMZF Plus 127 Neck Angle V40 Hip Stem #3; Catalog #6021-0335 Lot Code 35427003; Accolade TMZF Plus 127 Neck Angle V40 Hip Stem #5; Catalog #6021-0537 Lot Code 35202601
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution
Product Description
Total Hip Joint Replacement || Accolade TMZF Plus 127 Neck Angle V40 Hip Stem #3 || Accolade TMZF Plus 127 Neck Angle V40 Hip Stem #5 || Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 || A subsidiary of Stryker Corp. || Stryker France || ZAC Satolos Green Pusignan || Av de Staolas Green 69881 Metziae || Cedex France || The TMZF Press Fit HA Stem and TMZF Press Fit Plus HA Stem are intended for the reconstruction of the head and neck of the femoral joint. The device is intended for primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty. These stems can be used with any currently available Howmedica Osteonics acetabular components and V40 Femoral Heads that can be mated with a 5 40 BG taper.
Manufacturer
Stryker Howmedica Osteonics Corp.
1 Event
- Recall of Device Recall Total Hip Joint Replacement

Manufacturer

Stryker Howmedica Osteonics Corp.

Manufacturer Address
Stryker Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah NJ 07430
Manufacturer Parent Company (2017)
Stryker
Source
USFDA

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