Universal Compact Head Ring Adapter Plate — Class II medical device recall Z-0025-2016
Terminated recall by Integra LifeSciences Corp., reported 2015-10-14, distributed in NJ, TX, WY. Integra identified that the UCHRAP component (Arc Adapter Plate) would not assemble properly to the UCHRAR com
| Recall number | Z-0025-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Plainsboro, NJ, United States |
| Recall initiated | 2015-08-21 |
| Classified | 2015-10-06 |
| Reported by FDA | 2015-10-14 |
| Terminated | 2016-10-13 |
| Distributed | NJ, TX, WY |
| Countries outside the US | DE, DZ, IN |
| Quantity | 6 units |
| Serial numbers | 900, 901, 902, 904, 905, 906 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0025-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.