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Terminated

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.

FDA Recall Z-1052-2015 · Posted 2015-02-04

Recalling FirmZimmer, Inc.
Recall StatusTerminated
Product CodeOIY
Date Initiated2014-12-11
Date Terminated2015-10-23
Product Quantity67963

Reason for Recall

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.

Firm Action

Zimmer sent an URGENT MEDICAL DEVICE CORRECTION notifications letter dated December 11, 2014 to affected distributors via electronic mail, and all hospital Risk Managers and distributors with affected inventory via courier. The letter identified the affected product, problem, instructions for responding to the formal recall notification.and actions to be taken. For questions call the customer call center at 1-800-348-2759.

Root Cause

Device Design

Distribution Pattern

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, Switzerland, United Arab Emirates, and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123459ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEMZimmer, Inc. · 2013-02-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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