Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical Suture

• • Terminated Z-1535-2014 FDA Class II ·initiated 11 Mar 2014

  The product did not meet minimum and/or average minimum Teleflex resorption strength requirements.

• • Terminated Z-1012-2007 FDA Unclassified (pre-2012) ·initiated 6 Jun 2007

  The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.

• 4 recalls, same reason

  • Terminated Z-1019-2007 FDA Unclassified (pre-2012) ·initiated 6 Jun 2007
  • Terminated Z-1011-2007 FDA Unclassified (pre-2012) ·initiated 6 Jun 2007
  • Terminated Z-1014-2007 FDA Unclassified (pre-2012) ·initiated 6 Jun 2007
  • Terminated Z-1013-2007 FDA Unclassified (pre-2012) ·initiated 6 Jun 2007

  Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.

510(k) Number

K992088 ↗

FDA Product Code

GAM

Device Class

Class II

Regulation

21 CFR Part 878.4493

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Nextstitch Cardiovascular Valve Suture

  Class II

  FDA 510(k) K001440 Active Cleared 13 Nov 2000

• Rapid Transfer Blood Bag Model A-1650, Rapid Transfer Blood Bag Model S-250

  Class II

  FDA 510(k) K982712 Active Cleared 18 Dec 1998

• Saphlift

  Class I

  FDA 510(k) K990062 Active Cleared 30 Mar 1999

• Cutalon Nylon Polyamide Surgical Suture

  Class II

  FDA 510(k) K981322 Active Cleared 7 Jul 1998

• 'cottony' II Dacron, Silky II Polydek & Tevdek II Polyester Nonabsorbable Surgical Suture

  Class II

  FDA 510(k) K001434 Active Cleared 12 Jun 2000

• Endoscopic Camera

  Class II

  FDA 510(k) K991416 Active Cleared 20 Jul 1999

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