Recall Z-2107-2021
Arthrex, Inc. · initiated June 14, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
Codes / lots: Lots 12758314 and 13022357
Reason for recall
Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.
FDA-determined 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.
Details
- Recall number
- Z-2107-2021
- Initiated
- June 14, 2021
- Product code
- MAI – Fastener, Fixation, Biodegradable, Soft Tissue
- 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.
- Recalling firm
- Arthrex, Inc., Naples, FL