Z-1543-2023 Class II Ongoing
FDA device recall Z-1543-2023 was initiated by Linkbio Corp. on March 21, 2023 and is designated Class II. 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 cau… The recall status is ongoing. Affected quantity: 5 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 10, 2023
- Initiation Date
- March 21, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
Product Description
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2230/02
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
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
Code Information
UDI-DI: 04026575429127 All lot numbers within the labeled expiration date