Arthrex, Inc. Recall 88200
Description: Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
Arthrex, Inc. Recall 88200 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2107-2021 |
| Event ID | 88200 |
| Event Description | Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC |
| Product Type | Devices |
| 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. |
| Quantity | 3985 pieces |
| Recall Reason | Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch. |
| Device Classification | 20210728 |
| Device Code Info | Lots 12758314 and 13022357 |
| Center Classification Date | 20210721 |
| Recall Initiation Date | 20210614 |
| Recalling Firm | Arthrex, Inc. |
| Initial Notification | |
| Similar To |