The Recall Desk
ModerateFDA (Devices)·Z-0025-2016·Announced 2015-10-14

Integra Recalls Universal Compact Head Ring Adapter Plate Due to Assembly Error

Integra LifeSciences Corp. is recalling six Universal Compact Head Ring Adapter Plates that do not assemble properly due to a manufacturing drawing error.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a manufacturing error causing improper assembly, with no reported injuries or illnesses, fitting the criteria for a moderate severity recall.

Plain-English summary

Integra LifeSciences Corp. is recalling six units of the Universal Compact Head Ring Adapter Plate (UCHRAP). This component is part of the Universal Compact Head Ring Adapter (UCHRA), which is a component of the Integra CRW Precision Arc Stereotactic System.

The recall was initiated because the UCHRAP component would not assemble properly to the UCHRAR component (ARC Adapter Ring) of the Compact Head Ring Adapter. This issue was identified due to an error in the manufacturing drawing.

The affected units are identified by Catalog No. UCHRAP and Serial Nos. 900, 901, 902, 904, 905, and 906. The products were distributed worldwide, including to the United States states of New Jersey, Texas, and Wyoming, and to the countries of Algeria, Germany, and India. No specific instructions for consumers are provided in the source text.

The recalled product

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.
Affected units
6

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • Cat. No. UCHRAP
  • Serial No.s 900
  • 901
  • 902
  • 904
  • 905
  • 906

Distribution

Distributed in 3 states: