Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
FDA Recall Z-2107-2021 · Posted None
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Recalling FirmArthrex, Inc.
Recall StatusOpen, Classified
Product CodeMAI
Date Initiated2021-06-14
Product Quantity3985 pieces
Reason for Recall
Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.
Firm Action
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 [email protected] to answer questions regarding credit for affected devices in your possession.
Root Cause
Under Investigation by firm
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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