FDA recall Z-0253-2018

Product

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.

Reason for recall

Manufactured with the incorrect anchor outer body

Distribution

CA, IN, KS, MD, NY, OH, PA, TN, TX & WI

Key facts

Status

Terminated

Initiation date

2017-04-17

Report date

2017-12-20

Termination date

2021-08-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Utica, NY, United States

Primary source

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