Lower riskMedical device recall · FDA · Published June 14, 2021
Arthrex Suture Anchor Recall: Not Sterilized Due to Packaging Seal
Arthrex recalls specific suture anchors that may not be properly sterilized due to a packaging seal issue. Affected units include model AR-2323BCC with lots 12758314 and 13022357.
“Arthrex Suture Anchor Recall: Not Sterilized Due to Packaging Seal.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62340-arthrex-suture-anchor-recall-not-sterilized-due-to-packaging-seal. Based on FDA recall #Z-2107-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2107-2021%22&limit=1).
The FDA announced on June 14, 2021, that Arthrex, Inc. is recalling Suture Anchor, BioComposite SwiveLock C, REF AR-2323BCC because the outer pouch seal was improperly secured. The hazard is that the device may not be properly sterilized.
How to tell if you have it
Brand: Arthrex
Product: Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet
REF: AR-2323BCC
Lots: 12758314 and 13022357
Quantity: 3985 pieces
The hazard
The devices were not properly sterilized because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.
Context
GovInfoNow's records show Arthrex, Inc. has 12 other recalls on record since October 3, 2017. Other recent recalls of similar products include Medline Quick-Strip Bandages Recall (October 27, 2025), Alcon Custom Pak Sterility Risk (November 24, 2025), and Boston Scientific SC-4318 Clik X Anchor Recall (April 29, 2026).
How to tell if you have this one
Check for the model number AR-2323BCC with size 5.5 mm x 19.1 mm, Closed Eyelet, and lot numbers 12758314 or 13022357. These suture anchors were sold by Arthrex.
Brand
Arthrex
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify if your suture anchor has the model number AR-2323BCC with lot numbers 12758314 or 13022357.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 41 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 44 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2107-2021 (June 14, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2107-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.