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Devices
Device Recall Ball Head
Model / Serial
Part No. 194.01.28 194.02.28 194.03.28 195.01.32 195.02.32 195.03.32 188.01.28 188.02.28 188.03.28 188.04.28 188.05.28 189.01.32 189.02.32 189.03.32
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution including the states of CA, MD, TX, NV, and WI.
Product Description
Ball Head, 28 Short CERAMIC || Ball Head, 28 Medium CERAMIC || Ball Head, 28 Long CERAMIC || Ball Head, 32 Short CERAMIC || Ball Head, 32 Medium CERAMIC || Ball Head, 32 Long CERAMIC || Ball Head, 28 Short CoCr || Ball Head, 28 Medium CoCr || Ball Head, 28 Long CoCr || Ball Head, 28 X-Long CoCr || Ball Head, 28 XX-Long CoCr || Ball Head, 32 Short || Ball Head, 32 Medium || Ball Head, 32 Long
Manufacturer
Orthopedic Alliance LLC
1 Event
Recall of Device Recall Ball Head
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Manufacturer
Orthopedic Alliance LLC
Manufacturer Address
Orthopedic Alliance LLC, 26157 Jefferson Ave, Murrieta CA 92562-9561
Source
USFDA
Language
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