FDA (Devices) recall action 92088
The FDA (Devices) publishes a recall like this one as 48 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 48 pages.
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
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
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Linkbio Corp. is recalling 12 units of the LINK SLED Knee System due to risk of implant loosening and wear that could require revision surgery sooner than expected.
Linkbio Corp. is recalling 14 LINK SLED Knee implants due to risk of aseptic loosening and increased wear caused by improper surgical technique. The implants may fail earlier than expected, requiring revision surgery.
The LINK SLED Knee System requires updated surgical technique training due to risks of aseptic loosening and implant wear when improperly positioned or cemented. The manufacturer is issuing reinforced surgical guidelines and training to prevent unsatisfactory outcomes.
FDA recalls LINK SLED Knee System tibial components due to risk of aseptic loosening and premature wear. Patients may require revision surgery.
Linkbio Corp. recalls LINK SLED Knee System tibial component due to risk of early aseptic loosening caused by inadequate surgical technique. Training on improved surgical technique is being provided.
Linkbio Corp. is recalling 13 units of the LINK SLED knee implant component due to risk of early aseptic loosening or increased wear caused by suboptimal surgical positioning or inadequate cementing technique. Amended surgical technique guidance has been provided.
Linkbio Corp. is recalling 13 units of the LINK SLED Knee Implant All Poly Tibial Component due to risk of early aseptic loosening from suboptimal surgical positioning or inadequate cementing technique. Updated surgical technique guidance is being provided to prevent premature implant failure.
FDA is updating surgical instructions for the LINK SLED Knee System to address early aseptic loosening and increased wear from suboptimal positioning or inadequate cementing technique. Updated training aims to prevent implant failure and unexpected revision surgery.
Linkbio Corp. is recalling the LINK SLED Knee System tibial component due to risk of aseptic loosening and wear. The recall addresses concerns about suboptimal implant positioning or inadequate cementing technique that could lead to early revision surgery.
Linkbio Corp. recalls the LINK SLED Knee System due to risk of aseptic loosening from improper positioning or cementing technique, potentially requiring revision surgery. Five units affected in US and international distribution.
Linkbio Corp. is recalling the LINK SLED Knee System tibial component due to risk of early aseptic loosening and increased wear caused by suboptimal implant positioning or inadequate cementing technique.
Linkbio Corp. is recalling LINK SLED Knee System tibial components due to risk of early aseptic loosening and increased wear from improper implant positioning or inadequate cementing. Patients may require revision surgery earlier than expected.
Linkbio Corp. is recalling the LINK SLED Knee System tibial component (15 units) due to risk of early loosening and increased wear from inadequate surgical technique, potentially requiring earlier-than-expected revision surgery.
Linkbio Corp. is recalling 15 LINK SLED Knee System implants due to risk of aseptic loosening and wear from improper surgical technique. The company is providing amended surgical guidance and training to prevent implant failure.
The LINK SLED Knee System is recalled due to risk of early aseptic loosening and implant wear caused by suboptimal surgical positioning or inadequate cementing. The manufacturer is updating surgical guidance and providing additional training.
Linkbio Corp. recalls LINK SLED Knee System tibial component due to risk of aseptic loosening and implant wear from improper surgical technique, potentially requiring revision surgery.
Linkbio Corp. is recalling 13 units of the LINK SLED Knee System tibial component due to risk of aseptic loosening and increased wear. These risks arise from improper surgical positioning or inadequate cementing technique during implantation.
Linkbio Corp. is amending training for the LINK SLED Knee System due to early implant loosening and wear caused by inadequate surgical positioning and cementing techniques. Healthcare providers should implement updated surgical guidance.
The LINK SLED Knee System ALL POLY TIBIAL COMPONENT (18 units) is recalled due to early aseptic loosening and increased wear caused by suboptimal positioning or inadequate cementing technique, which may require earlier-than-expected revision surgery.
Linkbio Corp. is recalling 14 units of LINK SLED Knee System implants due to risk of early aseptic loosening or wear from suboptimal positioning or inadequate cementing. Updated surgical technique training is being issued.
Linkbio Corp. recalls 14 units of the LINK SLED Knee System tibial component due to risk of early aseptic loosening and increased wear from suboptimal implant positioning or inadequate cementing technique. Healthcare providers should follow updated surgical guidance.
Linkbio Corp. is recalling 15 units of the LINK SLED Knee System tibial component for risk of aseptic loosening and wear from improper implant positioning or inadequate cementing technique. Surgical training will be updated.
Linkbio Corp. is recalling LINK SLED Knee System tibial components due to risk of early loosening or increased wear caused by suboptimal implant positioning or inadequate cementing technique. Surgeons are being directed to update their technique and receive additional training.
The LINK SLED Knee System POREX ENDO tibial implant is recalled due to risk of early aseptic loosening or increased wear from suboptimal positioning or inadequate cementing. Affected patients may require early revision surgery.
Linkbio Corp. recalls the LINK SLED Knee Component due to risk of early aseptic loosening and implant wear. The issue stems from suboptimal implant positioning or inadequate cementing technique.