Medical device recalls Moderate risk

Zimmer Biomet, Inc. recalls Persona Partial Knee Spacer Blocks To assist in partial knee arthroplasty surgery

Recall date
October 24, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1240-2018
FDA classification
Class II
Brand / firm
Zimmer Biomet, Inc.
Sold / distributed
US Nationwide Distribution.

Why it was recalled

Zimmer Biomet is conducting a medical device recall for the Persona Partial Knee Spacer Blocks in sizes 8mm, 9mm, 10mm, 12mm, and 14mm. Complaints received indicated that flexion has the potential to feel tight during range-of-motion trialing and that the final trial has the potential to appear looser in extension.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Persona Partial Knee Spacer Blocks To assist in partial knee arthroplasty surgery

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