Integra LifeSciences Corporation: Medical Device Recall in 2013 - (Recall #: Z-1302-2013)

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:

Absorbable Collagen Sponge Provided As Intermediate to Another Company

Product Classification:

Class II

Date Initiated: March 28, 2013

Date Posted: May 22, 2013

Recall Number: Z-1302-2013

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: 84,460 boxes

Code Information:

1130055, 1130057, 1130228, 1130229, 1130388, 1105192, 1110821, 1110822, 1110987, 1111023, 1112020, 1112379, 1104815, 1110841, 1110842, 1110843, 1110953, 1110954, 1111022, 1111821, 1105206, 1110844, 1110903, 1110904, 1110931, 1110932, 1112021, 1104791, 1104961, 1105174, 1105453, 1105454, 1110826, 1110827, 1110969, 1111159, 1111160, 1104710, 1110828, 1111158, 1111764

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