Devices

Device Recall Femoral sponge.

Model / Serial
04230CE2, 04257CE2, 04286CE2, 04310CE2, 04334CE2, 05004CE2, 05041CE2, 05109CE2, 05200012, 05222012, 05292012, 05346012, 06038012, 06128012, 06172012, 06241012, 06268012, 06313012, 06348012, 07022012, 07031012, 07053012, 07081012, 07106012, 07136012, 07177012, 07192012, 07219012, 07253012, 07276012, 07320012, 07341012, 08010012, 08043012, 08063012, 08095012, 08127012, 08162012, 08177012, 08203012, 08249012, 08296012, 08325012, 08351012, 09040012, 09075012, 09106012 and 09138012.
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution -- United States, Canada, Mexico, Australia, Brazil, Switzerland, Japan, Netherlands, England, UK, Sweden, Hong Kong, Korea, Malaysia, Singapore, Argentina, Spain, and Italy.
Product Description
Bio-Prep Bone Preparation Kit with Merocel sponge for use in total hip arthroplasty. REF 206-730, Rx, Sterile, Stryker Instruments Kalamazoo, MI. || The femoral sponge is an absorbent that is used to dry the intramedullary canal prior to the application of bone cement. The suction effectively absorbs blood and fluid from the canal. It may provide swabbing/scrubbing action during suction.
Manufacturer
Stryker Instruments Div. of Stryker Corporation
1 Event
- Recall of Device Recall Femoral sponge.

Manufacturer

Stryker Instruments Div. of Stryker Corporation

Manufacturer Address
Stryker Instruments Div. of Stryker Corporation, 4100 E. Milham Ave., Kalamazoo MI 49001
Manufacturer Parent Company (2017)
Stryker
Source
USFDA

4 devices with a similar name

Learn more about the data here

Device Recall Femoral sponge.

Model / Serial
743288, 743289, 743330, 743331, 743332, 743333, 743362, 743363, 743364, 743365, 743378, 743379, 743380, 743381, 743390, 743391, 743400, 743402, 743403, 743404, 743405, 743418, 743419, 743420, 743421, 743422, 743423, 743445, 743446, 743447, 743448 and 743449.
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution -- United States, Canada, Mexico, Australia, Brazil, Switzerland, Japan, Netherlands, England, UK, Sweden, Hong Kong, Korea, Malaysia, Singapore, Argentina, Spain, and Italy.
Product Description
Femoral Sponge 10 inches REF 206-715, Rx Sterile, Stryker Instruments Kalamazoo, MI. || The femoral sponge is an absorbent that is used to dry the intramedullary canal prior to the application of bone cement. The suction effectively absorbs blood and fluid from the canal. It may provide swabbing/scrubbing action during suction.
Manufacturer
Stryker Instruments Div. of Stryker Corporation

Device Recall Femoral sponge.

Model / Serial
06292012, 07297012, 07354012 and 08164012.
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution -- United States, Canada, Mexico, Australia, Brazil, Switzerland, Japan, Netherlands, England, UK, Sweden, Hong Kong, Korea, Malaysia, Singapore, Argentina, Spain, and Italy.
Product Description
Advanced Cement Mixing Bio-Prep Cement Application Kit, Rx, Sterile, REF 306-563S10, Stryker Instruments, Kalamazoo, MI. || The femoral sponge is an absorbent that is used to dry the intramedullary canal prior to the application of bone cement. The suction effectively absorbs blood and fluid from the canal. It may provide swabbing/scrubbing action during suction.
Manufacturer
Stryker Instruments Div. of Stryker Corporation

Device Recall Femoral sponge.

Model / Serial
05068CS2 and 05210012.
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution -- United States, Canada, Mexico, Australia, Brazil, Switzerland, Japan, Netherlands, England, UK, Sweden, Hong Kong, Korea, Malaysia, Singapore, Argentina, Spain, and Italy.
Product Description
ACM with Femoral Brush and Femoral Sponge, Rx, Sterile, REF 306-705-000S8, Stryker Instruments, Kalamazoo, MI. || The femoral sponge is an absorbent that is used to dry the intramedullary canal prior to the application of bone cement. The suction effectively absorbs blood and fluid from the canal. It may provide swabbing/scrubbing action during suction.
Manufacturer
Stryker Instruments Div. of Stryker Corporation

Device Recall Femoral sponge.

Model / Serial
05257012 and 08129012.
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution -- United States, Canada, Mexico, Australia, Brazil, Switzerland, Japan, Netherlands, England, UK, Sweden, Hong Kong, Korea, Malaysia, Singapore, Argentina, Spain, and Italy.
Product Description
ACM Bio-Prep with Merocel pkg/6, Rx, Sterile, REF 0306-708-000S4, Stryker Instruments, Kalamazoo, MI. || The femoral sponge is an absorbent that is used to dry the intramedullary canal prior to the application of bone cement. The suction effectively absorbs blood and fluid from the canal. It may provide swabbing/scrubbing action during suction.
Manufacturer
Stryker Instruments Div. of Stryker Corporation

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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