Surgilon, Dermalon, & Ophthalon

• • Ongoing Z-2920-2026 FDA Class II ·initiated 24 Jun 2026

  Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.

• • Ongoing Z-0844-2024 FDA Class II ·initiated 21 Dec 2023

  Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.

• 2 recalls, same reason

  • Ongoing Z-1172-2023 FDA Class II ·initiated 2 Dec 2022
  • Ongoing Z-1178-2023 FDA Class II ·initiated 2 Dec 2022

  Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

• 5 recalls, same reason

  • Terminated Z-2821-2011 FDA Unclassified (pre-2012) ·initiated 3 Jun 2011 ·on shared 510(k) K981582
  • Terminated Z-2823-2011 FDA Unclassified (pre-2012) ·initiated 3 Jun 2011 ·on shared 510(k) K981582
  • Terminated Z-2820-2011 FDA Unclassified (pre-2012) ·initiated 3 Jun 2011 ·on shared 510(k) K981582
  • Terminated Z-2822-2011 FDA Unclassified (pre-2012) ·initiated 3 Jun 2011 ·on shared 510(k) K981582
  • Terminated Z-2824-2011 FDA Unclassified (pre-2012) ·initiated 3 Jun 2011 ·on shared 510(k) K981582

  Potential for the sterile barrier to be breached compromising the sterility of the product

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K981582 ↗

FDA Product Code

GAR

Device Class

Class II

Regulation

21 CFR Part 878.5020

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Multiclip Disp. Ligating Clip Device

  Class II

  FDA 510(k) K820999 Active Cleared 13 May 1982

• Argyle Quick- Picc Peripherally Inserted Central Catheter- Picc Trays, Argyle Quick- Picc Peripherally Inserted Central

  Class II

  FDA 510(k) K974015 Active Cleared 18 May 1998

• Dexon 's' Polyglycolic Acid Mesh

  Class II

  FDA 510(k) K830889 Active Cleared 9 May 1983

• Polyethylene Terephthalate (Pet) Pledget

  Class II

  FDA 510(k) K953425 Active Cleared 21 Aug 1995

• Davis & Geck Needle/Sharps Counter

  Class I

  FDA 510(k) K811191 Active Cleared 27 May 1981

• Biofix* Biodegradable Fixation Rod

  Class II

  FDA 510(k) K890902 Active Cleared 3 Nov 1989

See all devices from Davis & Geck, Inc. →

• What types of surgical procedures are these sutures intended for, and why is this important for clinicians?

  The SURGILON, DERMALON, and OPHTHALON sutures are designed for tissue approximation and ligation in general, plastic, and ophthalmic surgeries. This broad indication ensures durable support for soft tissues during wound closure and repair, making them versatile for procedures requiring long-term stability, such as skin grafts, plastic reconstructive work, or delicate eye surgeries. Clinicians benefit from this versatility as it reduces the need for multiple suture types in varied cases.

• Are these sutures single-use only, or can they be reused? How does this affect clinical workflow?

  The sutures are supplied in sterile, single-use packaging, though the device data does not explicitly restrict reuse. Clinicians may choose to reuse them based on clinical practice, provided proper sterilization protocols are followed. However, single-use packaging ensures sterility out-of-box, simplifying workflows in sterile environments like operating rooms where contamination risks are minimized. Reuse would require additional validation steps, such as sterilization and inspection, to maintain safety and efficacy.

• What storage conditions are required to maintain the sutures’ sterility and integrity, and why does this matter?

  The sutures must be stored under conditions that preserve sterility and integrity, though specific storage instructions (e.g., temperature, humidity) aren’t detailed here. This is critical because compromised packaging or exposure to contaminants could introduce infection risks during surgery. Clinicians should follow manufacturer guidelines (e.g., sealed, dry environments) to ensure the sutures remain uncontaminated until use, especially since they’re intended for delicate procedures where sterility is non-negotiable.

• How do I identify the correct suture size or model for my procedure, and what does the reference code (e.g., 3003495548) represent?

  The reference codes (e.g., `3003495548`) correspond to specific suture sizes, lengths, or packaging variants—details like gauge, needle type, or packaging (e.g., spooled vs. pre-attached needle) aren’t provided here, but they’re tied to clinical needs. For example, ophthalmic procedures may require finer sutures than plastic surgery. Always cross-reference the code with the manufacturer’s catalog or surgical guidelines to match the suture to your procedure’s demands, such as tissue type or tension requirements.

• What regulatory pathway was followed for these sutures, and what does this mean for their safety and equivalence?

  The sutures received FDA 510(k) clearance (K981582) under the Traditional 510(k) Review, determined to be *substantially equivalent* to prior nonabsorbable nylon sutures. This means the FDA evaluated them against a legally marketed predicate device and concluded they have the same intended use and safety profile. For clinicians, this implies rigorous testing for biocompatibility, performance, and manufacturing consistency—though it doesn’t guarantee suitability for every patient or procedure, as individual cases may vary.