FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp.: The UNI-CP System; Model Number: 330230SND.
- Recall number
- Z-1410-2017
- Recalling firm
- Integra LifeSciences Corp.
- Product
- The UNI-CP System; Model Number: 330230SND.
- Status
- Terminated
- Initiated
- 2017-01-25
- Posted
- not on file
- Terminated
- 2017-11-08
- Reason
- The firm received one complaint from one non-US sales representative (France) that the label on the UNI-CP plate was incorrect.
- Root cause
- Device Design
- Action
- Integra LifeSciences Corp. issued a recall letter/return response form on 1/25/2017.
- Quantity
- 39 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot # FEDT
- 510(k) numbers
- ["K011716"]
- PMA numbers
- not on file
- Product code
- JDR
- Firm FEI
- 3003418325
- Firm city
- Plainsboro
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28