Persona — Class II medical device recall Z-1052-2015
Terminated recall by Zimmer, Inc., reported 2015-02-11, distributed nationwide. Potential for delay in surgery and/or ball bearings to be left in the wound. Repeated cycles of sonic cleaning
| Recall number | Z-1052-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2014-12-11 |
| Classified | 2015-02-04 |
| Reported by FDA | 2015-02-11 |
| Terminated | 2015-10-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CA, CH, CZ, DE, DO, ES, FR, GB, IL, IN, IR, IT, JP, KR, LU, NL, SA, SE, SG, ZA |
| Quantity | 67,963 |
| Reason classes | device malfunction |
| Model numbers | 42-5279-002-00 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1052-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.