Class II — Arthrex, Inc.
| Recalling firm | ARTHREX, INC. |
|---|---|
| Registered facility | View this company's 20 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch. |
| Product | Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC |
| Quantity | 3985 pieces |
| 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. |
| Initiated | 2021-06-14 |
| Classified | 2021-07-21 |
| Recall number | Z-2107-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Arthrex, Inc. (Z-2107-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88200/
Alerts for ARTHREX, INC.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.