Class II — Zimmer, Inc.
| Recalling firm | ZIMMER, INC. |
|---|---|
| Registered facility | View this company's 10 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip. |
| Product | The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. Per the Persona Surgical technique, the Persona Tibial Articular Inserter is used to seat the articular surface implant onto the tibial baseplate. |
| Quantity | 618 units |
| Distribution | Worldwide Distribution - USA (nationwide) including the states of NY, OR, NC, OH, TX, FL, CO, IN, TN, PA, CA, KS, MO, WI, VA, MN, NJ, UT, MA, GA, MI, OK, AZ, MS, IL and AL., and the countries of Korea, Singapore, Canada and Japan |
| Initiated | 2014-10-07 |
| Classified | 2014-10-23 |
| Terminated | 2015-09-23 |
| Recall number | Z-0123-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Zimmer, Inc. (Z-0123-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69354/
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