Recall Z-0025-2016— Integra LifeSciences Corp.

Name: FDA recall Z-0025-2016
Creator: U.S. Food and Drug Administration
Published: 2015-08-21

Class II · Terminated

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2015-08-21, terminated 2016-10-13. It names one FDA 510(k) clearance: K944463. Product: Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The UCHRA is a component of the Integra¿ CRW¿ Precision Arc Stereotactic System.. Reason: Integra identified that the UCHRAP component (Arc Adapter Plate) would not assemble properly to the UCHRAR component (ARC Adapter Ring) of the Compact Head Ring Adapter due to an error in the manufacturing drawing..

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Terminated
Initiated: 2015-08-21
Terminated: 2016-10-13
Firm location: Plainsboro, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K944463 — CRW-1 SYSTEMRadionics Software Applications, Inc.·cleared 1995-10-26

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

Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The UCHRA is a component of the Integra¿ CRW¿ Precision Arc Stereotactic System.

Reason for recall

Integra identified that the UCHRAP component (Arc Adapter Plate) would not assemble properly to the UCHRAR component (ARC Adapter Ring) of the Compact Head Ring Adapter due to an error in the manufacturing drawing.

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