Medtronic Sofamor Danek USA Inc. is recalling approximately 275,260 units of the Catalyft PL and PL40 Expandable Interbody Systems because the implant cage may lose its intended height or collapse after being surgically implanted. This defect, known as a loss of lordosis, can cause the device to shift out of place, sink into the surrounding bone, or lead to neurological injury. Medtronic is updating the surgical technique and instructions for use to address and reduce this risk.
A collapse or loss of height in the implanted system can lead to device migration or bone subsidence, potentially causing significant nerve damage or chronic pain. In these instances, patients may require additional medical procedures or invasive revision surgery to correct the alignment and prevent further injury.
Affected Surgical Technique: M333023W217, Rev. 2.0; Affected IFU: M333023W048E Rev. A
Affected Surgical Technique: M333023W217, Rev. 2.0; Affected IFU: M333023W048E Rev. A
Affected Surgical Technique: M333023W217, Rev. 2.0; Affected IFU: M333023W048E Rev. A
Affected Surgical Technique: M333023W217, Rev. 2.0; Affected IFU: M333023W048E Rev. A
Affected Surgical Technique: M333023W217, Rev. 2.0; Affected IFU: M333023W048E Rev. A
Affected Surgical Technique: M333023W217, Rev. 2.0; Affected IFU: M333023W048E Rev. A
Affected Surgical Technique: M333023W217, Rev. 2.0; Affected IFU: M333023W048E Rev. A
Affected Surgical Technique: M333023W217, Rev. 2.0; Affected IFU: M333023W048E Rev. A
Affected Surgical Technique: M333023W217, Rev. 2.0; Affected IFU: M333023W048E Rev. A
Affected Surgical Technique: M333023W217, Rev. 2.0; Affected IFU: M333023W048E Rev. A
Affected Surgical Technique: M333023W217, Rev. 2.0; Affected IFU: M333023W048E Rev. A
Affected Surgical Technique: M333023W217, Rev. 2.0; Affected IFU: M333023W048E Rev. A
Affected Surgical Technique: M333023W217, Rev. 2.0; Affected IFU: M333023W048E Rev. A
Affected Surgical Technique: M333023W217, Rev. 2.0; Affected IFU: M333023W048E Rev. A
Affected Surgical Technique: M333023W217, Rev. 2.0; Affected IFU: M333023W048E Rev. A
Affected Surgical Technique: M333023W217, Rev. 2.0; Affected IFU: M333023W048E Rev. A
Affected Surgical Technique: M333023W217, Rev. 2.0; Affected IFU: M333023W048E Rev. A
Affected Surgical Technique: M333023W217, Rev. 2.0; Affected IFU: M333023W048E Rev. A
Affected Surgical Technique: M333023W217, Rev. 2.0; Affected IFU: M333023W048E Rev. A
Affected Surgical Technique: M333023W217, Rev. 2.0; Affected IFU: M333023W048E Rev. A
Affected Surgical Technique: M333023W217, Rev. 2.0; Affected IFU: M333023W048E Rev. A
Affected Surgical Technique: M333023W217, Rev. 2.0; Affected IFU: M333023W048E Rev. A
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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