FDA Medical Device Recalls (openFDA)
Zimmer, Inc.: 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.
- Recall number
- Z-0123-2015
- Recalling firm
- Zimmer, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2014-10-07
- Posted
- 2014-10-23
- Terminated
- 2015-09-23
- Reason
- Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip.
- Root cause
- Process control
- Action
- 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.
- 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
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K113369"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28