Arthrex, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2107-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC

Product Classification:

Class II

Date Initiated: June 14, 2021

Date Posted: July 28, 2021

Recall Number: Z-2107-2021

Event ID: 88200

Reason for Recall:

Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.

Status: Ongoing

Product Quantity: 3985 pieces

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.

Voluntary or Mandated:

Voluntary: Firm initiated