FDA Device recall Z-1052-2015
Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-5279-009-04
- FDA Device
- Class II
- terminated
- Published 2015-02-11
On 2015-02-11 the FDA classified a Class II recall of Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-5279-009-04 by Zimmer, citing 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 shi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1052-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-11 |
| Published | 2015-02-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | US |
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.
Identifiers
| code_info | Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-527…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 Lo |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1052-2015%22
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