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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Linkbio Corp.: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected; Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future

Agency Publication Date: May 4, 2023
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Affected Products

Product: LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 55MM Item Number: 15-2028/12

UDI-DI: 04026575044047 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 58MM Item Number: 15-2028/13

UDI-DI: 04026575359455 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9X58MM Item Number: 15-2028/14

UDI-DI: 04026575359462 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11X58MM Item Number: 15-2028/15

UDI-DI: 04026575359479 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13X58MM Item Number: 15-2028/16

UDI-DI: 04026575359486 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2030/02

UDI-DI: 04026575044061 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number: 15-2030/03

UDI-DI: 04026575044078 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2030/04

UDI-DI: 04026575044085 All lot numbers

Lot Numbers:
numbers
Product: LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2030/06

UDI-DI: 04026575044108 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2030/07

UDI-DI: 04026575044115 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2030/08

UDI-DI: 04026575044122 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2030/10

UDI-DI: 04026575044146 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2030/11

UDI-DI: 04026575044153 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2030/12

UDI-DI: 04026575044160 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2030/13

UDI-DI: 04026575436705 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2030/14

UDI-DI: 04026575436712 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2030/15

UDI-DI: 04026575436729 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2220/40

UDI-DI: 04026575429073 All lot numbers within expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2220/46

UDI-DI: 04026575429080 All lot numbers within expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2220/52

UDI-DI: 04026575429097 All lot numbers within expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, LARGE Item Number: 15-2220/60

UDI-DI: 04026575429103 All lot numbers the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2230/02

UDI-DI: 04026575429127 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number: 15-2230/03

UDI-DI: 04026575429134 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2230/04

UDI-DI: 04026575429141 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2230/06

UDI-DI: 04026575429165 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2230/07

UDI-DI: 04026575429172 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2230/08

UDI-DI: 04026575429189 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2230/10

UDI-DI: 04026575429202 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2230/11

UDI-DI: 04026575429219 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2230/12

UDI-DI: 04026575429226 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2230/13

UDI-DI: 04026575436736 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2230/14

UDI-DI: 04026575436743 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2230/15

UDI-DI: 04026575436750 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 55MM Item Number: 15-2028/10

UDI-DI: 04026575044023 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 55MM Item Number: 15-2028/11

UDI-DI: 04026575044030 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System: ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2020/40

UDI-DI: 04026575043897 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2020/46

UDI-DI:04026575209491 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2020/52

UDI-DI: 04026575043903 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System: ENDO SLED KNEE FEM COMP, Large Item Number: 15-2020/60

UDI-DI: 04026575043910 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 45MM Item Number: 15-2028/01

UDI-DI: 04026575043934 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 45MM Item Number: 15-2028/02

UDI-DI: 04026575043941 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 45MM Item Number: 15-2028/03

UDI-DI: 04026575043958 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 45MM Item Number: 15-2028/04

UDI-DI: 04026575043965 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 50MM Item Number: 15-2028/05

UDI-DI: 04026575043972 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 50MM Item Number: 15-2028/06

UDI-DI: 04026575043989 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 50MM Item Number: 15-2028/07

UDI-DI: 04026575043996 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 50MM Item Number: 15-2028/08

UDI-DI: 04026575044009 All lot numbers within the labeled expiration date

Lot Numbers:
numbers
Product: LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 55MM Item Number: 15-2028/09

UDI-DI: 04026575044016 All lot numbers

Lot Numbers:
numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92088
Status: Active
Manufacturer: Linkbio Corp.
Manufactured In: United States
Units Affected: 48 products (14 units; 18 units; 17 units; 12 units; 14 units; 13 units; 13 units; 14 units; 19 units; 15 units; 19 units; 24 units; 12 units; 13 units; 15 units; 14 units; 18 units; 15 units; 15 units; 18 units; 17 units; 15 units; 16 units; 14 units; 14 units; 20 units; 12 units; 20 units; 15 units; 13 units; 14 units; 16 units; 5 units; 4 units; 7 units; 5 units; 5 units; 5 units; 5 units; 5 units; 3 units; 5 units; 3 units; 3 units; 5 units; 5 units; 8 units; 5 units)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.