FDA recall Z-2107-2021

Arthrex, Inc. · Class II · device

Product

Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC

Reason for recall

Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.

Distribution

US Nationwide Distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and Hawaii.

Key facts

Status
Ongoing
Initiation date
2021-06-14
Report date
2021-07-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Naples, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2107-2021