FDA-Device2021-07-28Class II
Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
Arthrex, Inc.
Hazard
Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.
Sold states
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.
Affected count
3985 pieces
Manufactured in
1370 Creekside Blvd, N/A, Naples, FL, United States
Products
Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2107-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief