Recall Z-1410-2017
Integra LifeSciences Corp. · initiated January 25, 2017
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
The UNI-CP System; Model Number: 330230SND.
Codes / lots: Lot # FEDT
Reason for recall
The firm received one complaint from one non-US sales representative (France) that the label on the UNI-CP plate was incorrect.
FDA-determined cause: Device Design
Action taken
Integra LifeSciences Corp. issued a recall letter/return response form on 1/25/2017.
Details
- Recall number
- Z-1410-2017
- Initiated
- January 25, 2017
- Terminated
- November 8, 2017
- Product code
- JDR – Staple, Fixation, Bone
- Quantity
- 39 units
- Distribution
- Nationwide
- Recalling firm
- Integra LifeSciences Corp., Plainsboro, NJ