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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 145
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
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