LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2230/14
Reported: May 10, 2023 Initiated: March 21, 2023 #Z-1553-2023
Product Description
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2230/14
Reason for Recall
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
Details
- Recalling Firm
- Linkbio Corp.
- Units Affected
- 8 units
- Distribution
- 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
- Location
- Rockaway, NJ
Frequently Asked Questions
What product was recalled? ▼
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2230/14. Recalled by Linkbio Corp.. Units affected: 8 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 10, 2023. Severity: Moderate. Recall number: Z-1553-2023.
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