Recall Z-2056-2013— Integra Limited

Name: FDA recall Z-2056-2013
Creator: U.S. Food and Drug Administration
Published: 2013-07-17

Class II · Terminated

Class II FDA medical device recall by Integra Limited, initiated 2013-07-17, terminated 2014-10-01. It names one FDA 510(k) clearance: K902818. Product: 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.. Reason: 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..

Recalling firm: Integra Limited
Classification: Class II
Status: Terminated
Initiated: 2013-07-17
Terminated: 2014-10-01
Firm location: Plainsboro, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K902818 — MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENTRuggles Corp.·cleared 1990-09-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.