Integra LifeSciences Corporation: Medical Device Recall in 2013 - (Recall #: Z-1290-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Helitene Absorbable Collagen Hemostatic Sponge Helitene is indicated in surgical procedures (other than ophthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

Product Classification:

Class II

Date Initiated: March 28, 2013

Date Posted: May 22, 2013

Recall Number: Z-1290-2013

Event ID: 64778

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.

Status: Terminated

Product Quantity: 14, 525 boxes

Code Information:

1110788, 1112217 1110222, 1111357 1111602, 1105255 1110224, 1110225 1111601, 1110223 1110790, 1111603

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.

Voluntary or Mandated:

Voluntary: Firm initiated