Grappler Suture Anchor recall
Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System
Why was Grappler Suture Anchor recalled?
Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00889795114228, Lot: 5007499
- Product
- Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System
- Recalling firm
- Paragon 28, Inc.
- Quantity
- 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.
- Recall date
- September 28, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)