Devices

Device Recall Accolade TMZF Plus Hip Stem

Model / Serial
Catalog @ 3020-0537 Accolated TMZF Hip Stem # 5 Lot #31390203 8 units CAtalog #6020-3535 Accolade 132 Size 3.5 Lot #31446602R 0 units CAtalog # 6021-0230 Accolade Plus TMZF Hip Stem #2 Lot #31515703 10 units Catalog # 6021-0335 Accolade Plus TMZF Hipe Stem #3 Lot 31586402 10 units Catalog #3021-0435 Accolade TMZF Hipe STem #4 31597205 1 unit CAtalog # 6021-0435 Accolade Plus TMZF Hipe STem #4 Lot #31597206 4 units Catalog #6021-2530 Accolade (127 deg) Size 2.5 Accolade (127 deg) Size 2.5 Lot #31486505 10 units Catalog # 6021-4535 Accolade (127 DEG) Size 4.5 Lot #31850001 1 unit
Product Classification
Physical Medicine Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
Accolade TMZF Plus Hip Stem: || Catalog # 3020-0537 Accolate d TMZF Hip Stem # 5 || Catalog #6020-3535 Accolade 132 Size 3.5 || Catalog # 6021-0230 Accolade Plus TMZF Hip Stem #2 || Catalog # 6021-0335 Accolade Plus TMZF Hip Stem #3 || Catalog #3021-0435 Accolade TMZF Hip Stem #4 || Catalog # 6021-0435 Accolade Plus TMZF Hip Stem #4 || Catalog #6021-2530 Accolade (127 deg) Size 2.5 Accolade (127 deg) Size 2.5 || Catalog # 6021-4535 Accolade (127 DEG) Size 4.5 || K994366; k023105; K032300 || Manufactured by " Stryker Ireland, Carrigtwohill Industrial Estate Carrington County Cork, Ireland || The subject hip stem is a single-use device intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty.
Manufacturer
Stryker Howmedica Osteonics Corp.
1 Event
- Recall of Device Recall Accolade TMZF Plus Hip Stem

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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