PERSONA recallZ-0349-2018 · Zimmer Biomet, Inc. · initiated Jul 5, 2017
Terminated
Is my device affected?
- 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.
- If yours is listed, follow the instructions from Zimmer Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- 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
Finishing guide does not adequately account for shape differences present in Size 8 of Persona Partial Knee System, potentially resulting in additional surgery time or sensation of tightness during knee flexion.
FDA root cause category: Device Design
What the company is doing
Customers were notified via FedEx mail and email on approximately 07/05/2017. Instructions included to notify appropriate personnel, complete and return the Acknowledgement Form, return affected product, and provide contact information of additional hospitals or surgeons that used the affected product.
Recall details
- Recall number
- Z-0349-2018
- Status
- Terminated
- Initiated by the company
- Jul 5, 2017
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 158 devices
- Product code
- HSX
- FDA submissions
- K161592
- Distribution
- Distributed domestically to AZ, CA, CO, ID, IL, IN, MA, MD, MI, NJ, NM, PA, SC, TX, WA, WI. Distributed internationally to Belgium, France, Germany, Italy, Japan, Netherlands, Spain, Sweden, United Kingdom.
Product description
Persona Partial Knee System, Size 8, Finishing Guide
Code information (models, lots, serial numbers)
Item No. 42578100801, Lot No. 63518668, UDI (01)00880304809253(10)63518668. Item No. 42578100802, Lot No. 63518669, UDI (01)00880304809338(10)63518669.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Persona® 42-5781-008-01Zimmer, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- Persona® 42-5781-008-02Zimmer, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
Product lines
Other devices under the same FDA submission
73 devices cleared under K161592 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Persona® Partial Knee System 42-5580-004-02Biomet Orthopedics, LLC · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER12 reports
- Persona® Partial Knee System 42-5580-003-01Biomet Orthopedics, LLC · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER11 reports
- Persona® Partial Knee System 42-5380-005-02Biomet Orthopedics, LLC · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER11 reports
- Persona® 42-5181-007-08Zimmer, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER10 reports
- Persona® Partial Knee System 42-5282-005-08Biomet Orthopedics, LLC · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER10 reports
- Persona® Partial Knee System 42-5380-004-01Biomet Orthopedics, LLC · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER9 reports
- Persona® Partial Knee System 42-5380-006-01Biomet Orthopedics, LLC · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER9 reports
- Persona® 42-5181-006-08Zimmer, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER8 reports
- Persona® Partial Knee System 42-5380-007-02Biomet Orthopedics, LLC · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER8 reports
- Persona® Partial Knee System 42-5580-005-01Biomet Orthopedics, LLC · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER7 reports
- Persona® Partial Knee System 42-5380-005-01Biomet Orthopedics, LLC · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER7 reports
- Persona® Partial Knee System 42-5380-007-01Biomet Orthopedics, LLC · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER7 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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