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Devices
Device Recall Guide and KWires for T2 and Gamma Systems
Model / Serial
Catalog number 1806-0093S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
US Nationwide Distribution
Product Description
Stryker, T2 Guidewire, Smooth-Tipped, 2.2 x 800mm || Product Usage: || Intended for the temporary stabilization of bone segments or fragments.
Manufacturer
Stryker Howmedica Osteonics Corp.
1 Event
Recall of Device Recall Guide and KWires for T2 and Gamma Systems
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Manufacturer
Stryker Howmedica Osteonics Corp.
Manufacturer Address
Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2006
Manufacturer Parent Company (2017)
Stryker
Source
USFDA
14 devices with a similar name
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Device Recall Guide and KWires for T2 and Gamma Systems
Model / Serial
Catalog number 1210-6451S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
US Nationwide Distribution
Product Description
Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread || Product Usage: || Intended for the temporary stabilization of bone segments or fragments.
Manufacturer
Stryker Howmedica Osteonics Corp.
Device Recall Guide and KWires for T2 and Gamma Systems
Model / Serial
Catalog number 1213-9091S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
US Nationwide Distribution
Product Description
Stryker, Gamma Guide Pin, 4x400 mm || Product Usage: || Intended for the temporary stabilization of bone segments or fragments.
Manufacturer
Stryker Howmedica Osteonics Corp.
Device Recall Guide and KWires for T2 and Gamma Systems
Model / Serial
Catalog number 1320-0016S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
US Nationwide Distribution
Product Description
Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm || Product Usage: || Intended for the temporary stabilization of bone segments or fragments.
Manufacturer
Stryker Howmedica Osteonics Corp.
Device Recall Guide and KWires for T2 and Gamma Systems
Model / Serial
Catalog number 1806-0050S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
US Nationwide Distribution
Product Description
Stryker, T2 K-Wire, 3x285 mm || Product Usage: || Intended for the temporary stabilization of bone segments or fragments.
Manufacturer
Stryker Howmedica Osteonics Corp.
Device Recall Guide and KWires for T2 and Gamma Systems
Model / Serial
Catalog number 1806-0051S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
US Nationwide Distribution
Product Description
Stryker, T2 K-Wire with washer, 7.8 x 3 x 285mm || Product Usage: || Intended for the temporary stabilization of bone segments or fragments.
Manufacturer
Stryker Howmedica Osteonics Corp.
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