# FDA recall Z-2107-2021

> **Arthrex, Inc.** · Class II · device recall initiated 2021-06-14.

## 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

- **Recall number:** Z-2107-2021
- **Recalling firm:** Arthrex, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-06-14
- **Report date:** 2021-07-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Naples, FL, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-2107-2021. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-2107-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*