Integra Limited: Medical Device Recall in 2013 - (Recall #: Z-2056-2013)

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:

Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. The Leyla Retraction System, as part of the Ruggles brand of instruments is intended for use as a self-retaining retractor which is a self-locking device used to hold the edges of a wound open during neurosurgery.

Product Classification:

Class II

Date Initiated: July 17, 2013

Date Posted: September 4, 2013

Recall Number: Z-2056-2013

Event ID: 65824

Reason for Recall:

As a result of complaint investigations it was identified that there is a potential that the Leyla Ball Joint Clamp (R2383) may not provide the level of stability needed to maintain retraction in all cases.

Status: Terminated

Product Quantity: 65

Code Information:

Catalog Number R2383 and as a component of catalog number R2385, including all lot numbers date codes going back to January 2006.

Distribution Pattern:

Worldwide Distribution - USA including Puerto Rico and the states of AZ, CA, FL, GA, IL, IN, KY, MA, MI, MS, NE, NM, NY, OH, PA, TN, TX, UT, VA, WA, WI and WV., and the countries of Spain, Singapore, South Africa, Canada, Libya,Pakistan and Cayman Islands.

Voluntary or Mandated:

Voluntary: Firm initiated