FDA-Device2017-12-20Class II

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.

ConMed Corporation
Hazard

Manufactured with the incorrect anchor outer body

Sold states
CA, IN, KS, MD, NY, OH, PA, TN, TX & WI
Affected count
56 units
Manufactured in
525 French Rd, N/A, Utica, NY, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0253-2018

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