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 LINK SLED Knee System knee components due to risk of early aseptic loosening or increased wear. The company is issuing updated surgical technique guidance to address suboptimal implant positioning and cementing techniques.
Linkbio Corp. recalls 7 LINK SLED knee implants due to risk of early aseptic loosening and increased wear caused by suboptimal surgical technique. Affected units may require earlier-than-expected revision surgery.
Linkbio Corp. is recalling 5 units of the LINK SLED Knee System due to risk of early aseptic loosening or increased wear that could require earlier surgical revision. The recall addresses training and surgical technique to prevent implant failure.
Linkbio Corp. recalls LINK SLED Knee System implants due to risk of early loosening and increased wear caused by improper surgical technique. Updated training and labeling have been issued.
Linkbio Corp. is recalling LINK SLED Knee System prostheses due to risk of early aseptic loosening or increased wear caused by suboptimal surgical technique. The company is providing amended surgical guidelines and training.
Linkbio Corp. is issuing amended surgical technique guidance for its knee implant system to prevent early loosening and wear caused by improper positioning or inadequate cementing.
Linkbio Corp. is recalling LINK SLED Knee System tibial components due to risk of early aseptic loosening or premature wear caused by suboptimal implant positioning or inadequate cementing during surgery. The manufacturer is updating surgical technique guidance and training.
Linkbio Corp. is updating surgical technique guidance for the LINK SLED knee implant system to prevent early aseptic loosening or implant wear caused by suboptimal positioning or cementing technique during surgery.
Linkbio Corp. is issuing updated surgical technique guidance and training for the LINK SLED Knee System tibial component due to risk of early implant loosening or wear from suboptimal positioning or inadequate cementing.
A knee implant component is being recalled due to risks of early loosening or increased wear caused by suboptimal implant positioning or inadequate cementing. Manufacturers are providing updated surgical guidance.
The LINK SLED Knee System has been recalled due to risk of early aseptic loosening and wear caused by suboptimal implant positioning or inadequate cementing technique during surgery.
Linkbio Corp. is updating labeling and surgical technique training for the LINK SLED Knee System to prevent early aseptic loosening or excessive wear caused by improper implant positioning or inadequate cementing during surgery.
Linkbio Corp. is recalling the LINK SLED Knee System's all-poly tibial component due to risk of early aseptic loosening and increased wear from suboptimal implant positioning or inadequate cementing during surgery.
Linkbio Corp. is recalling 14 units of LINK SLED Knee System knee implant components due to risk of early loosening and wear caused by suboptimal implant positioning or inadequate cementing technique. Affected patients should contact their surgeon.
Linkbio Corp. recalls LINK SLED Knee System tibial component due to risks of early aseptic loosening and implant wear from improper surgical positioning or cementing technique.
Linkbio is recalling 15 LINK SLED Knee Systems due to potential aseptic loosening and wear from suboptimal implant positioning or inadequate cementing during surgery. Updated surgical technique training is required.
The LINK SLED Knee System tibial implant may experience early aseptic loosening if not positioned or cemented properly during surgery. Linkbio recommends updated surgical technique training for optimal implant placement.
Linkbio Corp. is recalling LINK SLED Knee System implants that may loosen prematurely due to improper positioning or cementing technique. Enhanced surgical training is being provided to prevent early device failure.
Linkbio Corp. is recalling LINK SLED Knee System implants that may loosen or wear prematurely due to improper surgical positioning or cementing, potentially requiring revision surgery. Updated surgical technique guidance is being provided.
The LINK SLED Knee System tibial component is being recalled due to risk of aseptic loosening caused by improper implant positioning or cementing technique, which could lead to early implant failure requiring revision surgery.
Linkbio Corp. is recalling the LINK SLED Knee System due to risk of early aseptic loosening and increased wear caused by improper surgical technique or positioning. The issue may require early revision surgery.
Linkbio Corp. is recalling the LINK SLED Knee System ALL POLY TIBIAL COMPONENT due to risk of early aseptic loosening or increased wear from suboptimal surgical placement or cementing, which may require early revision surgery.
LINK SLED Knee System tibial components are being recalled due to risk of early aseptic loosening and increased wear from suboptimal implant positioning or inadequate cementing technique. Surgical technique guidance is being issued.