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The Persona Tibial Articular Surface Inserter is a… recallZ-0123-2015 · Zimmer, Inc. · initiated Oct 7, 2014

Class II Terminated All recalls posted in October 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip.

FDA root cause category: Process control

What the company is doing

Zimmer sent an " URGENT MEDICAL DEVICE RECALL - LOT SPECIFIC " notifications dated September 2014, to all affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST.

Recall details

Recall number
Z-0123-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Oct 7, 2014
Posted by the FDA
Oct 23, 2014
Recalling firm
Zimmer, Inc.
Quantity
618 units
Product code
JWH
FDA submissions
K113369
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

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.

Code information (models, lots, serial numbers)

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.

Other devices under the same FDA submission

249 devices cleared under K113369 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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