FDA Device

Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126

Hazard

Label on the outer carton or the patient labels does not match label on the inner sterile packaging

What You Should Do

Remedy

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.

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Products

Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126
Brand
Zimmer Biomet, Inc.
UPC
Lot Number: J6255863 UDI: (01)00880304270794(17)280411(10)J6265594

Units Affected

8 units

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