Ti-Cron and Dacron Sutures

• 6 recalls, same reason

  • Terminated Z-2827-2011 FDA Unclassified (pre-2012) ·initiated 3 Jun 2011 ·on shared 510(k) K930591
  • Terminated Z-2826-2011 FDA Unclassified (pre-2012) ·initiated 3 Jun 2011 ·on shared 510(k) K930591
  • Terminated Z-2830-2011 FDA Unclassified (pre-2012) ·initiated 3 Jun 2011 ·on shared 510(k) K930591
  • Terminated Z-2825-2011 FDA Unclassified (pre-2012) ·initiated 3 Jun 2011 ·on shared 510(k) K930591
  • Terminated Z-2828-2011 FDA Unclassified (pre-2012) ·initiated 3 Jun 2011 ·on shared 510(k) K930591
  • Terminated Z-2829-2011 FDA Unclassified (pre-2012) ·initiated 3 Jun 2011 ·on shared 510(k) K930591

  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

K930591 ↗

FDA Product Code

GAT

Device Class

Class II

Regulation

21 CFR Part 878.5000

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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  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. →