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Manufacturers
Plus Orthopedics USA
Manufacturer Address
Plus Orthopedics USA, 10188 Telesis Ct, San Diego CA 92121-4779
Source
USFDA
17 Events
Recall of Device Recall VKS Tibial Trial
Recall of Device Recall VKS PE
Recall of Device Recall Gliding Nail
Recall of TCPLUS Solution
Recall of TCPLUS Solution
Recall of TCPLUS Solution
Recall of TCPLUS Solution
Recall of TCPLUS Solution
Recall of TCPLUS Solution
Recall of TCPLUS Solution
Recall of Device Recall UCPLUS Solution
Recall of Device Recall UCPLUS Solution
Recall of Device Recall Galileo Femoral Clamp
Recall of Device Recall Gliding Nail Radiolucent Guide instrument set
Recall of Device Recall VKS Knee System
Recall of TC-PLUS Solution Femoral Component, model 21028, Femoral component, right, size 8.
Recall of Device Recall MPF/ MPF GII / VKS
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17 devices in the database
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
Device Recall VKS PE
Model / Serial
Model Number: 0214612, Lot Number: 044159 No serial numbers
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide: USA including states of ID, NY, VA & WI
Product Description
VKS PE Tibia Insert Ultra-Congruent; Left, Size 2, 12mm; Model Number: 0214612; Plus Orthopedics, San Diego, CA 92121
Device Recall Gliding Nail
Model / Serial
Model Number: 0132073, Lot Number : 024332
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide: AZ and ID
Product Description
Plus Orthopedics Gliding Nail 17mm proximal / 11mm distal, 125 degrees, 180mm; Model Number: 0132073, Plus Orthopedics USA, San Diego, CA 92121
TCPLUS Solution
Model / Serial
Lot code: 0501.13.0200
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Arizona, California, Idaho, New York, Texas, and Virginia
Product Description
TC-PLUS Tibial Insert UC 10; 11mm, Model 25457
TCPLUS Solution
Model / Serial
Lot code: 0501.13.0199, 0303.13.1616
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Arizona, California, Idaho, New York, Texas, and Virginia
Product Description
TC-PLUS Tibial Insert UC 6; 13mm, Model 25438
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