Grappler Suture Anchor — Class II medical device recall Z-1776-2022
Ongoing recall by Paragon 28, Inc., reported 2022-09-28, distributed nationwide. Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery
| Recall number | Z-1776-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Paragon 28, Inc., Englewood, CO, United States |
| Recall initiated | 2022-07-13 |
| Classified | 2022-09-22 |
| Reported by FDA | 2022-09-28 |
| Distributed | Nationwide (US) |
| Quantity | 145 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00889795114228 |
| Lot numbers | 5007499 |
| Model numbers | P44-110-3010-SK |
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 for recall
Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1776-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.