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Linkbio Corp. Recall 92088

Description: LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2020/46

Linkbio Corp. Recall 92088 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1508-2023
Event ID92088
Event DescriptionLINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2020/46
Product TypeDevices
DistributionNY, 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
Quantity18 units
Recall ReasonAdditional 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
Device Classification20230510
Device Code InfoUDI-DI:04026575209491 All lot numbers within the labeled expiration date
Center Classification Date20230504
Recall Initiation Date20230321
Recalling FirmLinkbio Corp.
Initial Notification E-Mail
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