OrthoPediatrics Corp., a company focused exclusively on advancing the field of pediatric orthopedics, announced Monday, Sept. 11, it has received 510(k) clearance from the U.S. Food and Drug Administration for its Pediatric Nailing Platform | Tibia (“PNP Tibia”) surgical system.
Read MoreWARSAW — Zimmer Biomet has recently received a Form 483 notice from the FDA. The Form 483 is used by the FDA to document and communicate concerns discovered during routine inspections at the north campus location in Warsaw. The notice was sent to David Kunz, Senior Vice President after … Read More
WASHINGTON — Federal law-enforcement authorities are reminding consumers to avoid dangerous and unapproved decorative contact lenses this Halloween. According to officials, these illegal contact lenses sold at retail outlets and online can cause eye infections, conjunctivitis and impaired vision. U.S. Immigration and Customs Enforcement (ICE), U.S. Food and … Read More
SOUTH BEND — A lot of people know about the danger of salmonella poisoning from uncooked eggs in raw dough.
Read MoreWARSAW — The U.S. FDA is defending its response to a delay in reporting by MedTronic of injuries allegedly caused by its Infuse bone growth product. MassDevice cites a recent article by the Minneapolis StarTribune, which took an in-depth look at the situation and reported on MedTronic’s delay … Read More
WARSAW — The Food and Drug Administration has issued a warning to the Montreal, Quebec, Canada, plant of Zimmer-Biomet Inc. pertaining to requirement nonconformities. The Food and Drug Administration performed an inspection of the facility, ORTHOsoft Inc., earlier in May and completed the required Form 483 listing observations made … Read More
NEW YORK — Hostess Brands is recalling snack cakes and donuts because they may have come in contact with peanut residue.
Read MoreWARSAW — Zimmer Biomet Holdings, a global leader in musculoskeletal healthcare, announced it has received 510(k) clearance from the US Food and Drug Administration for the Unite3D Bridge Fixation System, a 3D-printed technology designed to offer stability in foot and ankle arthrodesis surgery. Featuring Zimmer Biomet’s proprietary OsseoTi porous … Read More
WARSAW — Nextremity Solutions Inc., a surgeon-driven, pure-play foot and ankle orthopedic company located in Warsaw, announced it has received 510(k) approval by the Food & Drug Administration to market its upcoming Axi+Line Proximal Bunion Correction System. “The Axi+Line Proximal Bunion Correction System represents a significant advancement in the … Read More
WARSAW — Zimmer Biomet Holdings, Inc., a global leader in musculoskeletal healthcare, is pleased to announce an expanded safety claim from the U.S. Food and Drug Administration for Gel-One® Cross-linked Hyaluronate, indicating that this single-injection viscosupplement for the knee joint is safe for use in repeat treatments. … Read More
By ANDY OBER InsideINdianaBusiness INDIANAPOLIS — Indianapolis-based Eli Lilly and Co. says the diabetes treatment Jardiance met its primary endpoint in a latest clinical trial. The company says the treatment lowered cardiovascular risk in adults with type 2 diabetes. Lilly says the long-term trial involved more than 7,000 … Read More
MINNESOTA — The Kraft Heinz Company has announced a voluntary recall of select varieties of Kraft Singles due to a potential choking hazard. The recall applies to three pound and four pound sizes of Kraft Singles American and White American pasteurized prepared cheese product. The company has said … Read More
INDIANAPOLIS — Kroger announced a recall Monday, July 27, of its store brand ground cinnamon, garlic powder, coarse ground black pepper and Bac’n Buds products because of possible salmonella contamination. The Food and Drug Administration tested a sample of garlic powder from a store in North Augusta, South … Read More
US Food and Drug Administration announced the filing of a consent decree against Medtronic – and two of the company’s officers – for violations related to the Synchromed II system.
Read MoreSilver Lake brand has voluntarily recalled all lots of its Easter egg cookies due to an ingredient that was not listed on the packaging. The company announced this morning that the cookies were being recalled because egg was not declared in the ingredients. People who have an allergy … Read More
A law to give terminally ill patients access to medicines that have passed Phase 1 of the FDA approval process but are not yet on pharmacy shelves is scheduled for a hearing and public testimony in the state Senate Health & Provider Services Committee on Wednesday. HB 1065, … Read More
