Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anch
FDA device recall Z-1776-2022 · posted 2022-09-22 · Open, Classified
Recall details
- Recalling firm
- Paragon 28, Inc.
- Reason for recall
- Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.
- Action taken
- 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 mkinnee@paragon28.com
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- MBI
- Quantity affected
- 145
- 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.
- Date initiated
- 2022-07-13
- Date posted
- 2022-09-22
- Location
- Englewood, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Grappler Suture Anchor System (K211002) | Paragon 28, Inc. | 2021-07-07 |