Device product
Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
Z-2107-2021
Product summary
- Firm
- Arthrex, Inc.
- Event
- Event 88200
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3985 pieces
- Official record key
device-enforcement:Z-2107-2021
Official wording
Reason: Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.
Code information: Lots 12758314 and 13022357
Distribution pattern: 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.
Derived failure modes
-
Unknown
Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.