Recalls / —
—#153110
Product
The UNI-CP System; Model Number: 330230SND.
- FDA product code
- JDR — Staple, Fixation, Bone
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K011716
- Affected lot / code info
- Lot # FEDT
Why it was recalled
The firm received one complaint from one non-US sales representative (France) that the label on the UNI-CP plate was incorrect.
Root cause (FDA determination)
Device Design
Action the firm took
Integra LifeSciences Corp. issued a recall letter/return response form on 1/25/2017.
Recalling firm
- Firm
- Integra LifeSciences Corp.
- Address
- 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344
Distribution
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-01-25
- Terminated
- 2017-11-08
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #153110. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.