Zimmer Biomet Persona Stemmed Tibial Prosthetic Right Leg Device Recall: Potential Cracks
Zimmer Biomet recalls Persona Stemmed Tibial Provisional Size H Right devices due to potential cracks in raw materials that could compromise cleanliness during orthopedic surgery.
Lower-risk recall
There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the raw material issue.
Contact the company
What happened, in plain English
Zimmer Biomet is recalling a specific surgical device that may have cracks in the raw materials. These cracks could allow contaminants to penetrate the instrument's surface, risking infection during surgery. Read more at govinfonow.com/recall/73171-zimmer-biomet-persona-stemmed-tibial-prosthetic-right-leg-device-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/73171-zimmer-biomet-persona-stemmed-tibial-prosthetic-right-leg-device-recall · Updated September 18, 2026 · FDA enforcement record: FDA #Z-1806-2018
Cite this page
“Zimmer Biomet Persona Stemmed Tibial Prosthetic Right Leg Device Recall: Potential Cracks.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73171-zimmer-biomet-persona-stemmed-tibial-prosthetic-right-leg-device-recall. Based on FDA recall #Z-1806-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1806-2018%22&limit=1).
Why it’s dangerous
The raw material batch may develop intermittent cracks. If these cracks penetrate the instrument's surface, contaminants could enter the device, potentially compromising surgical site cleanliness.
Who’s affected
Orthopedic surgeons and surgical teams using the recalled Persona Stemmed Tibial Provisional Size H Right device for temporary implants during surgery. The risk is primarily for those performing procedures with this specific device.
How to tell if you have this one
Check for the item number 42532108302 on the device. The recall includes devices with lot numbers 63683139 or 63613121, used in orthopedic surgery for temporary implants.
- Brand
Zimmer Biomet- Product
Persona Stemmed Tibial Provisional Size H Right, Item Number 42532108302 For use during orthopaedic surgery for- Category
Medical device
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI, and Puerto Rico; and to countries of: Australia, Canada, Hong Kong, India, Japan, Korea, Malaysia, Netherlands, and Singapore.
| Recall number | Product, codes & lots |
|---|---|
| Z-1805-2018 | Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301 For use during orthopaedic surgery for implantation of a prosthesis.; Lot 63535352, UDI (01)00889024246935(10)63607357; Lot 63535352, UDI (01)00889024246935(10)63535352 |
| Z-1806-2018 | Persona Stemmed Tibial Provisional Size H Right, Item Number 42532108302 For use during orthopaedic surgery for implantation of a prosthesis.; Lot 63683139, UDI (01)00889024246942(10)63683139; Lot 63613121, UDI (01)00889024246942(10)63613121 |
| Z-1807-2018 | Persona Cemented Tibial SZ PLT Size H Left, Item Number 42539908301 For use during orthopaedic surgery for implantation of a prosthesis.; Lot 63693589, UDI (01)00889024247574(10)63693589; Lot 63649575, UDI (01)00889024247574(10)63649575; Lot 63576035, UDI (01)00889024247574(10)63576035; Lot 63531869, UDI (01)00889024247574(10)63531869 |
| Z-1808-2018 | Persona Cemented Tibial SZ PLT Size H Right, Item Number 42539908302 For use during orthopaedic surgery for implantation of a prosthesis.; Lot 63688256, UDI (01)00889024247581(10)63688256; Lot 63576041, UDI (01)00889024247581(10)63576041; Lot 63531871, UDI (01)00889024247581(10)63531871 |
What to do — step by step
Check Device Details
Identify the item number (42532108302) and lot numbers (63683139 or 63613121) on the device.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 31 states.
FDA distribution: “Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI, and Puerto Rico; and to countries of: Australia, Canada, Hong…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas, Utah, Virginia, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1806-2018 (August 7, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1806-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.