Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2107-2021 — Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC

U.S. FDA — Device Enforcement · United States · 2021-06-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2107-2021
Date of alert
2021-06-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Arthrex, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
12758314
Reported risk: Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.