Z-2107-2021 Class II Ongoing
FDA device recall Z-2107-2021 was initiated by Arthrex, Inc. on June 14, 2021 and is designated Class II. Reason for recall: Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch. The recall status is ongoing. Affected quantity: 3985 pieces.
Recall Details
- Product Type
- Devices
- Report Date
- July 28, 2021
- Initiation Date
- June 14, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3985 pieces
Product Description
Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
Reason for Recall
Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.
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.
Code Information
Lots 12758314 and 13022357