Device recall

Z-2107-2021: Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF…

FDA device recall · Class II · Arthrex, Inc.

Key facts

Recall number (Z-number) Z-2107-2021
Recall event 88200
Product Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
Product code MAI
Recalling firm Arthrex, Inc.
Recall class Class II
Status Open, Classified
510(k) numbers K203495
FEI number 1220246

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)