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The devices were found to fail early and the manufacturer has announced a voluntary recall.

21, 2022 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. in March 2015 due to severe adverse effects reported by patients.

Inspections found elevated endotoxin levels on the parts.

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Zimmer Recalls 11, 658 Persona Knee Parts. Zimmer sent an “Urgent Medical Device Recall” letter to surgeons and risk managers, and then notified the Food and Drug Administration. Apr 10, 2015 · Walter Eisner • Fri, April 10th, 2015.

The recall notification included a description of the reason for the.

Your Zimmer Biomet sales representative will remove the affected product from your facility. Apr 10, 2015 · Walter Eisner • Fri, April 10th, 2015. A recall has been issued for all Zimmer Persona Knee Implants.

With little to no FDA review they were rushed to market with the hopes of offering previously undreamed-of levels of mobility to the thousands of people suffering from decreased range of motion and chronic pain due to deterioration of their knees. During this relatively common procedure, the natural joint is.

Class II.

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FDA Recall Notice / Source: FDA. Apr 10, 2015 · Zimmer Recalls 11, 658 Persona Knee Parts.

The recall comes as result of increasing reports of. .

The two main complaints associated with the implant were loosening and gaps between the implant and the bone.

<span class=" fc-smoke">Mar 9, 2018 · Zimmer, Inc. On March 12, 2015, the Food & Drug Administration announced the immediate recall of over 11,000 Zimmer Persona knee implant components because of premature loosening. .

Food and Drug Administration (FDA) 510(k) clearance for the Persona ® OsseoTi ® Keel Tibia for cementless knee replacement. The Zimmer. . Mar 9, 2018 · Zimmer, Inc. These gaps are an example of poor. .

A class II recall means the probability of death or serious injury is remote but the use of the recalled device may cause temporary or reversible adverse health consequences.

Zimmer created its first knee replacement device in 1968, and since then has revealed several. A recall has been issued for all Zimmer Persona Knee Implants.

During this relatively common procedure, the natural joint is.

fc-smoke">Apr 10, 2015 · Walter Eisner • Fri, April 10th, 2015.

Biomet – G7 Acetabular System, Dual Mobility Acetabular Liner, 40mm, Size D, Model # 110024462.

The Food and Drug Administration (FDA) gave the Persona knee implant expedited approval because.

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