Z-0123-2015 Class II Terminated
FDA device recall Z-0123-2015 was initiated by Zimmer, Inc. on Oct 7, 2014 and is designated Class II. Reason for recall: Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip. The recall status is terminated (terminated Sep 23, 2015). Affected quantity: 618 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 29, 2014
- Initiation Date
- Oct 7, 2014
- Termination Date
- Sep 23, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 618 units
Product Description
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.
Reason for Recall
Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip.
Distribution Pattern
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
Code Information
Part Number 42-5299-001-00 Lots: 56572679; 56573170; 56572918; 56573378; 56572975; 56573379; 56572978; 56574223; 56572981; 56574291; 56572982; 56574292; 56573071; 56574316; 56573115; 56574317; 56573116; 56574318; 56573154.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0123-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026