Recall Z-1052-2015— Zimmer, Inc.

Name: FDA recall Z-1052-2015
Creator: U.S. Food and Drug Administration
Published: 2014-12-11

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2014-12-11, terminated 2015-10-23. It names one FDA 510(k) clearance: K123459. Product: 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.. Reason: 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..

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-12-11
Terminated: 2015-10-23
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K123459 — ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEMZimmer, Inc.·cleared 2013-02-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.