Recall Z-2107-2021— Arthrex, Inc.

Name: FDA recall Z-2107-2021
Creator: U.S. Food and Drug Administration
Published: 2021-06-14

Class II · Ongoing

Class II FDA medical device recall by Arthrex, Inc., initiated 2021-06-14. It names one FDA 510(k) clearance: K203495. Product: Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC. Reason: Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch..

Recalling firm: Arthrex, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-06-14
Firm location: Naples, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K203495 — Arthrex SwiveLock AnchorArthrex, Inc.·cleared 2021-04-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC

Reason for recall

Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.

Data sourced from openFDA. This site is unofficial and independent of the FDA.