Recalls / —

—#201310

Product

NexGen Precoat Stemmed Tibial Plate Size 5

FDA product code

JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K173057

Affected lot / code info

Model No. 00598004701; UDI No./Lot. No.: (01)00889024217607(17)321228(10)J7418537/J7418537 and (01)00889024217607(17)321228(10)J7418542/J7418542.

Why it was recalled

Device outer packaging was incorrectly labeled.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

The firm distributed recall notifications by email on 5/19/2023. Customers are asked to review the recall notification and distribute to team members so they are aware of its contents. Additionally, customers are to identify and quarantine any affected devices, complete the provided Inventory Return Certification form, and ship affected product back to Zimmer. Customers are to retain a copy of the Inventory Return Certification for their records. Customers with any questions may call 574-371-3071 or email CorporateQuality.PostMarket@zimmerbiomet.com.

Recalling firm

Firm

Zimmer, Inc.

Address

1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern

International distribution in the country of India.

Timeline

Recall initiated

2023-05-19

Posted by FDA

2023-07-05

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #201310. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.