Persona Stemmed Tibial Provisional Size H Right, Item Number 42532108302 For use during orthopaedic surgery for implantation of a prosthesis.
Check against the official notice below — it lists the full affected range.
Zimmer Biomet, Inc. is recalling 842 units of Persona Stemmed Tibial Provisional Size H Right surgical instruments used during orthopaedic surgery. The recall affects two specific lots (63683139 and 63613121) distributed nationwide across the United States, Puerto Rico, and nine other countries including Canada, Australia, and Japan. The products are being recalled because the raw material batch used to manufacture them contains a potential for intermittent cracks, which could compromise the cleanliness of the instruments if cracks penetrate the surface.
The recall notice does not specify a remedy or recommended course of 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 63683139, UDI (01)00889024246942(10)63683139; Lot 63613121, UDI (01)00889024246942(10)63613121
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.