Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-1507-2023

March 21, 2023

Class II

Product summary

Firm
Linkbio Corp.
Event
Event 92088
Status
Ongoing
Classification
Class II
Quantity
14 units
Official record key
device-enforcement:Z-1507-2023

Official wording

Reason: 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

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

Distribution pattern: NY, NV Foreign: Bulgaria, France, Italy, Norway, Poland, Sweden, Switzerland, Slovakia, Spain, United Kingdom, Germany, Austria, Argentina, Australia, China, India, Iraq, Jordan, Colombia, Mexico, Saudi Arabia, Ukraine, Vietnam, and Belarus

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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