Persona Cemented Tibial SZ PLT Size H Left, Item Number 42539908301 For use during orthopaedic surgery for implantation of a prosthesis.
Check against the official notice below — it lists the full affected range.
Zimmer Biomet has recalled 842 units of Persona Cemented Tibial SZ PLT Size H Left orthopaedic implants used during joint replacement surgery. The affected products come from four specific lot numbers (63693589, 63649575, 63576035, and 63531869) and were distributed worldwide, including throughout the United States and to Australia, Canada, Hong Kong, India, Japan, Korea, Malaysia, the Netherlands, and Singapore. The recall was issued because the raw material batch used to manufacture these products may contain intermittent cracks that could compromise the cleanliness of the instruments if the cracks penetrate the product surface.
The source document does not specify a remedy or recommend any action for affected consumers.
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 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.