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Devices
Device Recall VKS Tibial Trial
Model / Serial
Model Numbers/Lot Codes: 1214331/EM.1 and EM.6, 1214332/EM.1 and EM.6, 1214333/EM.1, 1214334/EM.5, and 1214335/EM.1
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide to : AZ, CA, CO, FL, ID, NE, NY, SC, TX, UT, VA, and WA
Product Description
VKS Tibial Trial, Right/Left, Prep Guide; Model Number: 1214331, 1214332, 1214333, 1214334, 1214335: ( Model Number: 1214331 VKS Tibial Prep Guide, Right/Left, Size 1, Lot Code EM. 1 and EM.6; 1214332 VKS Tibial Prep Guide, Right/Left, Size 2 Lot Code EM.l and EM.6, 1214333 VKS Tibial Prep Guide, Right/Left, Size 3 Lot Code EM.1; 1214334 VKS Tibial Prep Guide, Right/Left, Size 4 Lot Code EM.5; 1214335 YKS Tibial Prep Guide, Right/Left, Size 5 Lot Code EM), Plus Orthopedics
Manufacturer
Plus Orthopedics USA
1 Event
Recall of Device Recall VKS Tibial Trial
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Manufacturer
Plus Orthopedics USA
Manufacturer Address
Plus Orthopedics USA, 10188 Telesis Ct, San Diego CA 92121-4779
Source
USFDA
Language
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