Persona Cemented Tibial SZ PLT Size H Right, Item Number 42539908302 For use during orthopaedic surgery for implantation of a prosthesis.
Check against the official notice below — it lists the full affected range.
Zimmer Biomet is recalling 842 Persona Cemented Tibial SZ PLT Size H Right prosthetic components used in orthopedic surgery due to potential intermittent cracks in the raw material batch. These cracks could compromise the cleanliness of the affected products if they penetrate the instrument's surface. The recalled products are from three specific lots: 63688256, 63576041, and 63531871.
The affected products were distributed worldwide, including throughout the United States (in 32 states and Puerto Rico), and to Australia, Canada, Hong Kong, India, Japan, Korea, Malaysia, Netherlands, and Singapore. The source document does not specify a remedy or instructions for what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for 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. 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. Quantity: 842 products in total Lot/code info: Lot 63688256, UDI (01)00889024247581(10)63688256; Lot 63576041, UDI (01)00889024247581(10)63576041; Lot 63531871, UDI (01)00889024247581(10)63531871
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.