WARSAW — 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 inspections were performed from September to November …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 Drug Administration (FDA), and U.S. Customs and …read more.

SOUTH BEND — A lot of people know about the danger of salmonella poisoning from uncooked eggs in raw dough.

WARSAW — 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 in reporting. The company disputed the story …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 during the inspection, including violations. It was …read more.

NEW YORK — Hostess Brands is recalling snack cakes and donuts because they may have come in contact with peanut residue.

WARSAW — 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 metal technology, which mimics the architecture of …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 treatment of moderate to severe hallux valgus …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.   Gel-One Hyaluronate is administered in the physician …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 patients from 42 countries. at high risk …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 a “thin strip of the individual packaging …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 Carolina, and found it to be contaminated …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.

Silver 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 or severe sensitivity to eggs could have …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, The Indiana Right to Try Act, is …read more.

Eli Lilly and Company (NYSE: LLY) has received its third US Food and Drug Administration (FDA) approval for CYRAMZA® (ramucirumab). Specifically, CYRAMZA is now also indicated in combination with docetaxel, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. Patients with epidermal growth factor receptor (EGFR) or …read more.

Eli Lilly and Company announced yesterday that the European Commission granted marketing authorization for Trulicity (dulaglutide) solution for injection. Trulicity, a GLP-1 receptor agonist, is a once-weekly, injectable solution designed to improve glycaemic control in adults with type 2 diabetes. The medicine comes in a ready-to-use pen with a pre-attached, hidden needle. Trulicity received a …read more.

Zimmer Holdings Inc. (NYSE: ZMH; SIX: ZMH), today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration to market iASSIST Knee, the Personalized Guidance System for knee replacement procedures. iASSIST represents a revolutionary next step in surgical guidance, providing simple, intuitive and accurate intraoperative feedback and alignment validation to surgeons …read more.