Zimmer Biomet Recalls Persona Cemented Tibial Plate Due to Cracks
Zimmer Biomet is recalling 842 Persona Cemented Tibial Plate units because potential cracks in the raw material could compromise the cleanliness of the instruments.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 (medical device) where the hazard is a potential cleanliness compromise due to material cracks, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Zimmer Biomet, Inc. is recalling 842 units of the Persona Cemented Tibial SZ PLT Size H Right (Item Number 42539908302). These orthopaedic surgical implants are used for the implantation of a prosthesis. The affected lots are 63688256, 63576041, and 63531871.
The recall is due to a potential for intermittent cracks in the raw material batch used to produce these products. If these cracks penetrate the surface of the instrument, the cleanliness of the affected products could be compromised.
The products were distributed worldwide, including nationwide in the United States and in several international countries. Healthcare facilities and patients who have received these specific implants should contact their healthcare provider or Zimmer Biomet for further instructions.
The recalled product
- Product
- Persona Cemented Tibial SZ PLT Size H Right, Item Number 42539908302 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 (6)
- Lot 63688256
- UDI (01)00889024247581(10)63688256
- Lot 63576041
- UDI (01)00889024247581(10)63576041
- Lot 63531871
- UDI (01)00889024247581(10)63531871
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 · material defect
See all →- HighICU Medical Recalls Plum Administration Sets Due to Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- ModerateParagon 28 Recalls Custom Foot Implant Due to Material Defect
FDA (Devices) · 2026-08-26
- LowParagon 28 Recalls Custom Foot Implant Due to Material Defect
FDA (Devices) · 2026-08-26
- HighNexxZr dental zirconia discs may have reduced or missing dentin layer
FDA (Devices) · 2026-06-17
Similar recalls
- SevereZimmer Recalls Persona Knee System Tibial Sizing Plates
FDA (Devices) · 2012-12-26
- SevereZimmer Persona Tibial Sizing Plate Recalled for Perforation Risk
FDA (Devices) · 2012-12-26
- SevereZimmer Persona Knee System Tibial Sizing Plates Recalled for Perforation Risk
FDA (Devices) · 2012-12-26
- HighZimmer Persona Trabecular Metal Tibial Plate Recall for Loosening Complaints
FDA (Devices) · 2015-03-18
- SevereZimmer Recalls Persona Knee Implants Due to Tibial Perforation Risk
FDA (Devices) · 2012-12-26
- SevereZimmer Recalls Persona Knee Implants to Reduce Tibial Perforation Risk
FDA (Devices) · 2012-12-26