Arthrex, Inc. Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
Brand
Arthrex, Inc.
Lot Codes / Batch Numbers
Lots 12758314 and 13022357
Products Sold
Lots 12758314 and 13022357
Arthrex, Inc. is recalling Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC due to Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.
Recommended Action
Per FDA guidance
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 FLS@arthrex.com to answer questions regarding credit for affected devices in your possession.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026