Home / Recalls / Integra LifeSciences Corporation / Z-1298-2013

Z-1298-2013 Class II Terminated

Recalled by Integra LifeSciences Corporation — Plainsboro, NJ

Recall Details

Product Type
Devices
Report Date
May 22, 2013
Initiation Date
March 28, 2013
Termination Date
June 3, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
812 boxes

Product Description

OraMem Absorbable Collagen Membrane OraMem¿ Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.

Reason for Recall

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Distribution Pattern

Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.

Code Information

1112066

Other recalls by Integra LifeSciences Corporation

  • Z-2777-2016 Class II — Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only Me (March 11, 2016)
  • Z-1084-2015 Class II — The MAYFIELD¿ Ultra 360 Base Unit for head positioner, one unit per package. (December 19, 2014)
  • Z-1697-2014 Class II — Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 28 (March 28, 2014)
  • Z-1736-2013 Class II — Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal (May 9, 2013)
  • Z-1288-2013 Class II — INSTAT - Agent, Absorbable Hemostatic, Collagen Based INSTAT MCH is recommend (March 28, 2013)
  • Z-1283-2013 Class II — Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regenerat (March 28, 2013)
  • Z-1291-2013 Class II — Colla Tape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbab (March 28, 2013)
  • Z-1301-2013 Class II — BioMend Absorbable Collagen Membrane BioMend¿ Absorbable Collagen Membrane is (March 28, 2013)
  • Z-1300-2013 Class II — Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an (March 28, 2013)
  • Z-1282-2013 Class II — Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant for (March 28, 2013)