Recall Z-2107-2021 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
Arthrex, Inc.
Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
| Date | Jun 14, 2021 |
| Status | Open, Classified |
| Reason | Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch. |
| Root cause | Under Investigation by firm |
| Action | On June 14, 2021 the firm e-mail their consignees with the following instructions: Immediately discontinue use, sale, and distribution of the affected lots of product. and to contact the Field Logistics Services at FLS@arthrex.com to answer questions regarding credit for affected devices in your possession. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203495 | Arthrex SwiveLock Anchor Arthrex, Inc., Apr 19, 2021 |