Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301 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 units of the Persona Stemmed Tibial Provisional Size H Left (Item Number 42532108301), a surgical instrument used during orthopedic surgery for prosthesis implantation. The recall was issued because the raw material batch used to produce these products has the potential for intermittent cracks that could compromise the cleanliness of the instruments if the cracks penetrate the surface.
The affected products were distributed nationwide across 32 U.S. states and Puerto Rico, as well as internationally to Australia, Canada, Hong Kong, India, Japan, Korea, Malaysia, the Netherlands, and Singapore. The recalled items are from Lot 63535352 under two UDI codes: (01)00889024246935(10)63607357 and (01)00889024246935(10)63535352. The source document does not specify a remedy 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 63535352, UDI (01)00889024246935(10)63607357; Lot 63535352, UDI (01)00889024246935(10)63535352
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.