Zimmer Biomet Recalls Persona Stemmed Tibial Provisional Instruments
Zimmer Biomet is recalling 842 Persona Stemmed Tibial Provisional instruments due to potential cracks in the raw material that could compromise cleanliness.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (potential cleanliness compromise) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Zimmer Biomet, Inc. is recalling 842 units of the Persona Stemmed Tibial Provisional Size H Left (Item Number 42532108301). These medical devices are used during orthopaedic surgery for the implantation of a prosthesis.
The recall is issued because there is a potential for intermittent cracks in the raw material batch used to produce the affected products. If these cracks penetrate the surface of the instrument, the cleanliness of the products could be compromised.
The affected products were distributed nationwide in the United States to specific states and Puerto Rico, as well as to several international countries including Australia, Canada, and Japan. Healthcare facilities and patients who have used these specific instruments should contact Zimmer Biomet for further instructions.
The recalled product
- Product
- Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301 For use during orthopaedic surgery for implantation of a prosthesis.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 842
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot 63535352
- UDI (01)00889024246935(10)63607357
- UDI (01)00889024246935(10)63535352
Distribution
Part of a larger recall action
This product is one of 4 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Zimmer Biomet, Inc.
See all →- HighZimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
- ModerateZimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
- HighZimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11
Same hazard · contamination
See all →- HighMedline Recalls Surgical Convenience Kits Due to Contaminated Components
FDA (Devices) · 2026-09-02
- HighMedline Recalls 263 Surgical Convenience Kits Due to Contamination
FDA (Devices) · 2026-09-02
- HighMedline Recalls 71 Convenience Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02
- HighMedline C-Section Convenience Kits Recalled for Contaminated Components
FDA (Devices) · 2026-09-02
- HighMedline Recalls 419 Surgical Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02