Medical device recalls Moderate risk

ConMed Corporation recalls Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures may be us…

Recall date
April 17, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0253-2018
FDA classification
Class II
Brand / firm
ConMed Corporation
Sold / distributed
CA, IN, KS, MD, NY, OH, PA, TN, TX & WI

Why it was recalled

Manufactured with the incorrect anchor outer body

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

What was recalled

Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures may be used in either arthroscopic or open surgical procedures.

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