Zimmer, Inc. recalls Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-527…

Recall date

December 11, 2014

Source

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

Recall number

Z-1052-2015

FDA classification

Class II

Brand / firm

Zimmer, Inc.

Sold / distributed

Worldwide Distribution - USA Nationwide including DC, and PR and the countries of Australia, Austria, Belgium, Canada, Czech Republic, Dominican Republic, France, Germany, India, Iran, Israel, Italy, Japan, Luxembourg, Netherlands, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden,…

Why it was recalled

Potential for delay in surgery and/or ball bearings to be left in the wound. Repeated cycles of sonic cleaning can break down the ball bearing retention feature (swage) on the shim. To prevent this, TASP shims must be manually cleaned and inspected per product insert, 87-6203-991-22.

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 (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-5279-009-04. Product Usage: The Persona TASPs are sterilizable instruments Intended for multiple uses. The TASP components are used to aid the surgeon in assessing the thickness of the articular surface required. The TASP construct is utilized while conducting a trial range of motion. The TASP consists of 3 parts: a TASP bottom, a TASP shim, and a TASP top. The shims come in varying thicknesses to allow trialing for specific Articular Surface implant thicknesses.