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FDA Device recall Z-0025-2016

Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The UCHRA is a component…

On 2015-10-14 the FDA classified a Class II recall of Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The UCHRA is a component… by Integra Lifesciences, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0025-2016
ClassificationClass II
Statusterminated
Initiated2015-08-21
Published2015-10-14
Last updated2026-09-13 11:53 UTC
CompanyIntegra Lifesciences
DistributionNJ, TX, WY

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.

Identifiers

code_infoCat. No. UCHRAP; Serial No.s 900, 901, 902, 904, 905, 906

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0025-2016%22

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