CLASS II ONGOING Device recall · Reported 28 Sep 2022 · FDA Enforcement Report
Grappler Suture Anchor, Titanium, 3.0, Sterile Kit recalled
Paragon 28 is recalling Grappler Suture Anchor, Titanium, 3.0, Sterile Kit, distributed nationwide in the US. The recall was initiated on 13 Jul 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1776-2022
- FDA event ID
- 90753
- Recalling firm
- Paragon 28, Englewood, CO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Jul 2022
- FDA classified
- 22 Sep 2022
- Reported
- 28 Sep 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 13 Jul 2022 | Recall initiated by company | |
| 22 Sep 2022 | Classified by FDA | +71 days |
| 28 Sep 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System
Where it was distributed
US Nationwide distribution in the states of AZ, IN, LA, NJ, TX, WA, NY, MD, WI, OK, KY, MI, OH, CA, FL, KS, PA.
Nationwide ArizonaCaliforniaFloridaIndianaKansasKentuckyLouisianaMarylandMichiganNew JerseyNew YorkOhioOklahomaPennsylvaniaTexasWashingtonWisconsin
Questions about this recall
Why was it recalled?
Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.
Which lots are affected?
UDI-DI: 00889795114228, Lot: 5007499
Where was it sold?
US Nationwide distribution in the states of AZ, IN, LA, NJ, TX, WA, NY, MD, WI, OK, KY, MI, OH, CA, FL, KS, PA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Device | CLASS III | Custom Made Device Implant 6123 Navicular Cage Nominal Right recalled | Paragon 28 | Other | Nationwide |
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Other Surgical Instruments recalls
All 3,902| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline surgical convenience kits labeled as: EAR recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Convenience Kits containing Conmed AirSeal Access Ports recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline surgical convenience kits labeled as recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Scout MD recalled by Merit Medical Systems | Merit Medical Systems | Other | 7 states |
| Device | CLASS II | Convenience Kits containing Conmed AirSeal Access Ports recalled | Medline Industries | Packaging Defects | Nationwide |