Arthrex, Inc. recalls Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
- Recall date
- June 14, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2107-2021
- FDA classification
- Class II
- Brand / firm
- Arthrex, Inc.
- Sold / distributed
- 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.
Why it was recalled
Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
Get recall alerts
Free email alert whenever Arthrex, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Arthrex, Inc.