Grappler Suture Anchor System recallZ-1776-2022 · Paragon 28, Inc. · initiated Jul 13, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Paragon 28, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.
FDA root cause category: Device Design
What the company is doing
On 7/13/22, recall notices were emailed to distributors who were asked to do the following: 1) Review physical inventory of product within your control and at a hospital/health care facility within your region. Any affected product that is identified is to be discontinued, quarantined and not distributed any further. 2) Return affected devices to the recalling firm. 3) Complete and return the Recall Response form. For inquiries, contact the recalling firm at [email protected]
Recall details
- Recall number
- Z-1776-2022
- Status
- Open, Classified
- Initiated by the company
- Jul 13, 2022
- Posted by the FDA
- Sep 22, 2022
- Recalling firm
- Paragon 28, Inc.
- Quantity
- 145
- Product code
- MBI
- FDA submissions
- K211002
- Distribution
- US Nationwide distribution in the states of AZ, IN, LA, NJ, TX, WA, NY, MD, WI, OK, KY, MI, OH, CA, FL, KS, PA.
Product description
Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System
Code information (models, lots, serial numbers)
UDI-DI: 00889795114228, Lot: 5007499
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Grappler™ Suture Anchor System P44-110-3010-SKParagon 28, Inc. · Fastener, fixation, nondegradable, soft tissue1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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