Zimmer Manufacturing B.V. recalls Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm Sterile. For use in t…

Recall date

March 17, 2016

Source

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

Recall number

Z-1340-2016

FDA classification

Class II

Brand / firm

Zimmer Manufacturing B.V.

Sold / distributed

Distributed in US (AL, AZ, CA, GA, HI, ID, KS, LA, MA, MN, MO, NY, OH, OK, PA, TX, UT, VA, and WI) and foreign countries (Korea, Japan, Germany, Singapore, Austria, Italy, South Africa, and Spain).

Why it was recalled

The firm received a customer complaint establishing that the product (Persona PS Articular Surfaces)information shown on the box differed by sides. One side showed P/N: 42-5114-008-18/ Lot: 62632101 and the other side showed P/N: 42-5114-005-14/ Lot: 62646580.

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

What was recalled

Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm Sterile. For use in total knee arthroplasty. REF 42-5114-005-14