FDA Device recall Z-1776-2022
Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System
- FDA Device
- Class II
- ongoing
- Published 2022-09-28
On 2022-09-28 the FDA classified a Class II recall of Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System by Paragon 28, citing suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1776-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-07-13 |
| Published | 2022-09-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Paragon 28 |
| Distribution | US |
Product
Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System
Reason
Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.
Identifiers
| code_info | UDI-DI: 00889795114228, Lot: 5007499 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1776-2022%22
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