Zimmer, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1052-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 11, 2014

Date Posted: February 11, 2015

Recall Number: Z-1052-2015

Event ID: 70240

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.

Status: Terminated

Product Quantity: 67963

Code Information:

Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-5279-009-04: 42-5279-002-00 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, CD, 10mm; 42-5279-002-02 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, CD, 12mm; 42-5279-002-04 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, CD, 14mm; 42-5279-004-00 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, EF, 10mm; 42-5279-004-02 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, EF, 12mm; 42-5279-004-04 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, EF, 14mm; 42-5279-006-00 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, GH, 10mm; 42-5279-006-02 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, GH, 12mm; 42-5279-006-04 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, GH, 14mm; 42-5279-008-00 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, J, 10mm; 42-5279-008-02 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, J, 12mm; 42-5279-008-04 All Lots Persona Constrained TASP (Tibial A/S Prov.) Shim, J, 14mm; 42-5279-003-00 All Lots Persona TASP (Tibial A/S Provisional) Shim, CD, 10mm; 42-5279-003-01 All Lots Persona TASP (Tibial A/S Provisional) Shim, CD, 11mm; 42-5279-003-02 All Lots Persona TASP (Tibial A/S Provisional) Shim, CD, 12mm; 42-5279-003-03 All Lots Persona TASP (Tibial A/S Provisional) Shim, CD, 13mm; 42-5279-003-04 All Lots Persona TASP (Tibial A/S Provisional) Shim, CD, 14mm; 42-5279-005-00 All Lots Persona TASP (Tibial A/S Provisional) Shim, EF, 10mm; 42-5279-005-01 All Lots Persona TASP (Tibial A/S Provisional) Shim, EF, 11mm; 42-5279-005-02 All Lots Persona TASP (Tibial A/S Provisional) Shim, EF, 12mm; 42-5279-005-03 All Lots Persona TASP (Tibial A/S Provisional) Shim, EF, 13mm; 42-5279-005-04 All Lots Persona TASP (Tibial A/S Provisional) Shim, EF, 14mm; 42-5279-007-00 All Lots Persona TASP (Tibial A/S Provisional) Shim, GH, 10mm; 42-5279-007-01 All Lots Persona TASP (Tibial A/S Provisional) Shim, GH, 11mm; 42-5279-007-02 All Lots Persona TASP (Tibial A/S Provisional) Shim, GH, 12mm; 42-5279-007-03 All Lots Persona TASP (Tibial A/S Provisional) Shim, GH, 13mm; 42-5279-007-04 All Lots Persona TASP (Tibial A/S Provisional) Shim, GH, 14mm.

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.

Voluntary or Mandated:

Voluntary: Firm initiated