Device 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.
Z-0123-2015
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 69354
- Status
- Terminated
- Classification
- Class II
- Quantity
- 618 units
- Official record key
device-enforcement:Z-0123-2015
Official wording
Reason: Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip.
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.
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
Derived failure modes
-
Unknown
Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip.