The Recall Desk
HighFDA (Devices)·Z-1776-2022·Announced 2022-09-28

FDA Recalls Grappler Suture Anchors Due to Potential Breakage Risk

Paragon 28, Inc. is recalling Grappler Suture Anchors (REF: P44-110-3010-SK, Lot 5007499) due to risk that the anchor may break upon insertion, potentially leaving debris in patients and delaying surgery.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm medical device with potential for serious patient impact (surgical debris, procedure delays), but no reported injuries or adverse events. Per the severity rubric, risk-of-harm products where injury has not yet been reported score at 3 (High).

Plain-English summary

Paragon 28, Inc. is recalling the Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit (REF: P44-110-3010-SK), specifically lot number 5007499. This device is for use within the Grappler Suture Anchor System.

The suture anchor may break upon insertion, potentially leaving debris in the patient and delaying surgery.

Approximately 145 units were distributed nationwide to medical facilities in Arizona, Indiana, Louisiana, New Jersey, Texas, Washington, New York, Maryland, Wisconsin, Oklahoma, Kentucky, Michigan, Ohio, California, Florida, Kansas, and Pennsylvania.

The recalled product

Product
Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System
Manufacturer
Paragon 28, Inc.
Category
Medical Device — Surgical Anchor
Hazard
  • breakage
  • debris
  • device-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • UDI-DI: 00889795114228
  • Lot: 5007499

Distribution

Distributed nationwide across the United States.

Related recalls

Same category