Integra LifeSciences Corp. d.b.a. Integra Pain Management: Medical Device Recall in 2016 - (Recall #: Z-2733-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND

Product Classification:

Class II

Date Initiated: August 24, 2016

Date Posted: September 14, 2016

Recall Number: Z-2733-2016

Event ID: 75028

Reason for Recall:

Integra LifeSciences has been notified of a medical device recall by Adaptive Surgical, LLC involving their Riverlon" Nylon 3-0 Sutures that are packaged in Integras Cranial Access Kits. It was found that product seals may become open during extreme distribution conditions and render the device unsterile.

Status: Terminated

Product Quantity: 710

Code Information:

Lot W1605101: Exp 2016-12 Lot W1605103: Exp 2016-11 Lot W1605106: Exp 2016-11 Lot W1606063: Exp 2016-12 Lot W1605101: Exp 2016-12 W1605103: 2016-11 W1605106: 2016-11 W1606063: 2016-12

Distribution Pattern:

Nationwide and VA/govt/military. No foreign consignees.

Voluntary or Mandated:

Voluntary: Firm initiated