FDA Device recall Z-2107-2021
Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
- FDA Device
- Class II
- ongoing
- Published 2021-07-28
On 2021-07-28 the FDA classified a Class II recall of Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC by Arthrex, citing not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2107-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-06-14 |
| Published | 2021-07-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Arthrex |
| Distribution | US |
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.
Identifiers
| code_info | Lots 12758314 and 13022357 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2107-2021%22
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