—#198031

Product

(1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses. Item Number: 183104 (2) Vanguard Knee System PS Open Box Femoral; Right; 62.5 mm Item Number: 183106 (3) Vanguard Knee System PS Open Box Femoral; Right; 65 mm Item Number: 183108 (4) Vanguard Knee System PS Open Box Femoral; Right; 67.5 mm Item Number: 183110 (5) Vanguard Knee System PS Open Box Femoral; Right; 70 mm Item Number: 183112

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K113550
Affected lot / code info: (1) UDI: (01)00880304270770(17)320408(10)J7209534 Lot Number: J7209534 Expanded Recall: Lot Numbers/UDI: J7197497 (01)00880304270770(17)320504(10)J7197497, J7215873 (01)00880304270770(17)320428(10)J7215873, J7220365 (01)00880304270770(17)320504(10)J7220365, J7220368 (01)00880304270770(17)320504(10)J7220368. (2) Lot Numbers/UDI: J7133633 (01)00880304270787(17)320504(10)J7133633; J7175232 (01)00880304270787(17)320504(10)J7175232. (3) Lot Number/UDI: J7173881 (01)00880304270794(17)320504(10)J7173881; (4) Lot Number/UDI: J7220405 (01)00880304270080(17)320504(10)J7220405. (5) Lot Number /UDI: J7215860 (01)00880304270817(17)320505(10)J7215860.

Why it was recalled

Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).

Root cause (FDA determination)

Labeling Change Control

Action the firm took

UPDATE: 2/7/23 Zimmer Biomet issued URGENT MEDICAL DEVICE RECALL EXPANSION Letter on 2/07/23 to Distributors, Risk Manager, Surgeons. (An Urgent Medical Device Letter issued to consignees new accounts not previously notified Dec 29, 2022). Letters state reason for recall, health risk and action to take: This is a 14-lot scope expansion to the recall notification initiated on December 29, 2022, for the Vanguard Posterior Stabilized Open Box Femoral components. Letter states reason for recall, health risk and action to take: . Immediately locate and quarantine affected product in your inventory. Return all affected product from your distributorship and from affected hospitals within your territory. . Complete Inventory Return Certification Form for each return and send to CorporateQuality.PostMarket@zimmerbiomet.com, even if you do not have affected products available to return in your territory. . If you have further questions 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. Or your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com. ______________________________________________________________________ Zimmer Biomet issued Urgent Medical Device Recall via email on December 29, 2022. OUS Distributors notified via email. Hospital risk managers and surgeons, as well as distributors with product notified via courier. Surgeons will be provided with a letter that identifies the issue and their responsibilities, which include: - Following any specified patient monitoring instructions. - Returning Certificate of Acknowledgment to Zimmer Biomet.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: International distribution to the countries of: Argentina, China, Costa Rica, India, Japan, Mexico, Netherlands, Ecuador, Republic of Korea, Singapore, and Thailand. Expanded Recall US states of: FL, IN, MD, OH, PA, WI

Timeline

Recall initiated: 2022-12-29
Posted by FDA: 2023-01-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #198031. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.