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Devices
Device Recall TCPLUS(TM), Primary Fixed Tibial Component VKS
Model / Serial
Batch numbers: B1514883, B1509344, B1504926, B1502141.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
International Distribution only in countries of: Germany and Switzerland.
Product Description
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 026, S&N; 7500281, Smith & Nephew Orthopaedics AG || Product Usage: Tibial knee prosthesis
Manufacturer
Smith & Nephew, Inc.
1 Event
Recall of Device Recall TCPLUS(TM), Primary Fixed Tibial Component VKS
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Manufacturer
Smith & Nephew, Inc.
Manufacturer Address
Smith & Nephew, Inc., 1450 E Brooks Rd, Memphis TN 38116-1804
Manufacturer Parent Company (2017)
Smith & Nephew plc
Source
USFDA
14 devices with a similar name
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Device Recall TCPLUS(TM), Primary Fixed Tibial Component VKS
Model / Serial
Batch number C1507672
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
International Distribution only in countries of: Germany and Switzerland.
Product Description
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 0012, S&N; 7500267, Smith & Nephew Orthopaedics AG || Product Usage: Tibial knee prosthesis
Manufacturer
Smith & Nephew, Inc.
Device Recall TCPLUS(TM), Primary Fixed Tibial Component VKS
Model / Serial
Batch number C1507674
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
International Distribution only in countries of: Germany and Switzerland.
Product Description
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12 000 0013, S&N; 7500268, Smith & Nephew Orthopaedics AG || Product Usage: Tibial knee prosthesis
Manufacturer
Smith & Nephew, Inc.
Device Recall TCPLUS(TM), Primary Fixed Tibial Component VKS
Model / Serial
Batch Number C1507852
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
International Distribution only in countries of: Germany and Switzerland.
Product Description
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 2 LEFT, STERILE R, REF 12 000 002, S&N; 7500257, Smith & Nephew Orthopaedics AG || Product Usage: Tibial knee prosthesis
Manufacturer
Smith & Nephew, Inc.
Device Recall TCPLUS(TM), Primary Fixed Tibial Component VKS
Model / Serial
Batch number C1507158
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
International Distribution only in countries of: Germany and Switzerland.
Product Description
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 005, S&N; 7500260, Smith & Nephew Orthopaedics AG || Product Usage: Tibial knee prosthesis
Manufacturer
Smith & Nephew, Inc.
Device Recall TCPLUS(TM), Primary Fixed Tibial Component VKS
Model / Serial
Batch number C1507675
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
International Distribution only in countries of: Germany and Switzerland.
Product Description
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 10 LEFT, STERILE R, REF 12 000 006, S&N; 7500261, Smith & Nephew Orthopaedics AG || Product Usage: Tibial knee prosthesis
Manufacturer
Smith & Nephew, Inc.
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