Recalls / —
—#168792
Product
Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108
- FDA product code
- JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K023546, K113550
- Affected lot / code info
- Lot Number: J6265594 UDI: (01)00880304270893(17)280411(10)J6255863
Why it was recalled
Label on the outer carton or the patient labels does not match label on the inner sterile packaging
Root cause (FDA determination)
Labeling mix-ups
Action the firm took
Zimmer issued recall letter on 10/22/18 via email and FedEx. Acountts requested to immediately locate and quarantine affected product in your inventory. Return affected product from your distributorship and from affected hospitals. Complete Inventory Return Certification Form. uestions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday.
Recalling firm
- Firm
- Zimmer Biomet, Inc.
- Address
- 56 E Bell Dr, Warsaw, Indiana 46582-6989
Distribution
- Distribution pattern
- AR, MO, MN, NJ, NY, OH, MN , NJ, VA
Timeline
- Recall initiated
- 2018-10-22
- Terminated
- 2019-12-11
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #168792. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.