Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
This recall is currently active, issued June 14, 2021. It was issued by Arthrex, Inc..
- Company
- Arthrex, Inc.
- Recall Initiated
- June 14, 2021
- Recall Number
- Z-2107-2021
- Quantity
- 3985 pieces
- Firm Location
- Naples, FL
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Lots 12758314 and 13022357
Root Cause
Under Investigation by firm
Action Taken
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.