Home / Recalls / Integra LifeSciences Corporation / Z-1282-2013

Z-1282-2013 Class II Terminated

Recalled by Integra LifeSciences Corporation — Plainsboro, NJ

FDA device recall Z-1282-2013 was initiated by Integra LifeSciences Corporation on March 28, 2013 and is designated Class II. 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. The recall status is terminated (terminated June 3, 2015). Affected quantity: 15,607 boxes.

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
15,607 boxes

Product Description

Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes..

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

1125807, 1125802, 1125806, 1125804, 1125808, 1111845, 1125805, 1125803, 1125809, 1125810, 1130069, 1130061, 1130064, 1130065, 1130417, 1130521, 1110850, 1111839, 1111621, 1110274, 1105302, 1110669, 1111618, 1112228, 1110160, 1110670, 1111606, 1111616, 1104916, 1111614, 1111615, 1110273, 1111277, 1111849, 1110667, 1104918, 1110853, 1111619, 1111842, 1110666, 1112109, 1112108, 1104917, 1110854, 1111620, 1110276, 1105301, 1111846, 1112225, 1110851, 1111617, 1105303, 1110852, 1110270, 1105304, 1110246, 1112222, 1112224, 1110245, 1111844, 1111850, 1110668, 1125522, 1125628, 1104879, 1110814, 1111610, 1125525, 1104876, 1110815, 1111607, 1125526

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-1292-2013 Class II — CollaCote Absorbable Collagen Wound Dressing for Dental Surgery The Absorbabl (March 28, 2013)
  • Z-1285-2013 Class II — DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is (March 28, 2013)
  • Z-1283-2013 Class II — Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regenerat (March 28, 2013)
  • Z-1288-2013 Class II — INSTAT - Agent, Absorbable Hemostatic, Collagen Based INSTAT MCH is recommend (March 28, 2013)
  • Z-1296-2013 Class II — OraTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable (March 28, 2013)
  • Z-1294-2013 Class II — HeliTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable (March 28, 2013)

FDA data resources