Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System
Recall
- Recall Number
- Z-1776-2022
- Event Number
- 90753
- Firm
- Paragon 28, Inc. 14445 Grasslands Dr Englewood CO 80112-7062
- FEI Number
- 3008650117
- Product Code
- MBI
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- July 13, 2022
- Posted
- September 22, 2022
Description
Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System
Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.
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]
US Nationwide distribution in the states of AZ, IN, LA, NJ, TX, WA, NY, MD, WI, OK, KY, MI, OH, CA, FL, KS, PA.
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