FDA Device recall Z-1531-2023
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2030/07
- FDA Device
- Class II
- ongoing
- Published 2023-05-10
On 2023-05-10 the FDA classified a Class II recall of LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2030/07 by Linkbio, citing additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased we….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1531-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-21 |
| Published | 2023-05-10 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Linkbio |
| Distribution | NV, NY |
Product
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2030/07
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
Identifiers
| code_info | UDI-DI: 04026575044115 All lot numbers within the labeled expiration date |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1531-2023%22
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