Zimmer Manufacturing B.V. recalls Product 50 consists of all product under product code: JWH and same usage: Item no: 595002701 NEXGEN MIS TIBIA PLATE PR…

Recall date

January 11, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1148-2016

FDA classification

Class II

Brand / firm

Zimmer Manufacturing B.V.

Sold / distributed

US Nationwide Distribution

Why it was recalled

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Product 50 consists of all product under product code: JWH and same usage: Item no: 595002701 NEXGEN MIS TIBIA PLATE PR 595002702 NEXGEN MIS TIBIA PLATE PR 595003701 NEXGEN MIS TIBIA PLATE PR 595003702 NEXGEN MIS TIBIA PLATE PR 595003712 NEXGEN MIS TIBIA PLATE PR 595004701 NEXGEN MIS TIBIA PLATE PR 595004702 NEXGEN MIS TIBIA PLATE PR 595005701 NEXGEN MIS TIBIA PLATE PR 595005702 NEXGEN MIS TIBIA PLATE PR for use in total knee arthroplasty