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Recall Observatory FDA recall evidence

Device product

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

Z-2107-2021

June 14, 2021

Class II

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

    reason.no_named_rule · v1.0.0

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