Versys 6 inch Beaded Full Coat Plus Hip Prosthesis.
Modèle / numéro de série
a. Item No. 00784301906 (Lot Expiration Date Before 05/31/2025); b. Item No. 00784302106 (Lot Expiration Date Before 06/30/2025); c. Item No. 00784302206 (Lot Expiration Date Before 01/31/2026); d. Item No. 00784301936 (Lot Expiration Date Before 06/30/2026); e. Item No. 00784302036 (Lot Expiration Date Before 01/31/2026); f. Item No. 00784302136 (Lot Expiration Date Before 02/28/2025); g. Item No. 00784302236 (Lot Expiration Date Before 07/31/2026); h.Item No. 00784301406 (Lot Expiration Date Before 07/31/2026); i. Item No. 00784301506 (Lot Expiration Date Before 06/30/2026); j. Item No. 00784301606 (Lot Expiration Date Before 06/30/2026); k. Item No. 00784301706 (Lot Expiration Date Before 06/30/2026); l. Item No. 00784301806 (Lot Expiration Date Before 03/31/2026); m. Item No. 00784301826 (Lot Expiration Date Before 04/30/2026); n. Item No. 00784301926 (Lot Expiration Date Before 11/30/2025); o. Item No. 00784302006 (Lot Expiration Date Before 11/30/2025); p. Item No. 00784302026 (Lot Expiration Date Before 07/31/2026); q. Item No. 00784302126 (Lot Expiration Date Before 07/31/2026); r. Item No. 00784302226 (Lot Expiration Date Before 09/30/2025); s. Item No. 00784301746 (Lot Expiration Date Before 07/31/2026); t. Item No. 00784301756 (Lot Expiration Date Before 07/31/2025): u. Item No. 00784301836 (Lot Expiration Date Before 07/31/2026); v. Item No. 00784301846 (Lot Expiration Date Before 07/31/2026); w. Item No. 00784301856 (Lot Expiration Date Before 06/30/2026); x. Item No. 00784301946 (Lot Expiration Date Before 07/31/2026); y. Item No. 00784301956 (Lot Expiration Date Before 09/30/2025); z. Item No. 00784302046 (Lot Expiration Date Before 07/31/2026); aa.Item No. 00784302056 (Lot Expiration Date Before 07/31/2026); ab. Item No. 00784302146 (Lot Expiration Date Before 07/31/2026); ac. Item No. 00784302156 (Lot Expiration Date Before 07/31/2026); ad. Item No. 00784302246 (Lot Expiration Date Before 07/31/2026); ae. Item No. 00784302256 (Lot Expiration Date Before 07/31/2026)
Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and Puerto Rico; and to countries of: Austria, Australia, Bahamas, Brazil, Canada, China, Dominican Republic, England, France, Germany, Israel, Japan, South Korea, Lebanon, Malaysia, Mexico, Netherlands, Panama, Singapore, Spain, Switzerland, and Thailand.
Description du dispositif
Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows: || a. VERSYS 6 INCH BEADED FC 19X160MM STD BODY STD NECK (Item No. 00894301906); || b. VERSYS 6 INCH BEADED FC 21X160MM STD BODY STD NECK (Item No. 00784302106); || c. VERSYS 6 INCH BEADED FC 22X160MM STD BODY STD NECK (Item No. 00784302206); || d. VERSYS 6 INCH BEADED FC STEM 19X160MM LM (Item No. 00784301936); || e. VERSYS 6 INCH BEADED FC STEM 20X160MM LM (Item No. 00784302036); || f. VERSYS 6 INCH BEADED FC STEM 21X160MM LM (Item No. 00784302136); || g. VERSYS 6 INCH BEADED FC STEM 22X160MM LM (Item No. 00784302236); || h. VERSYS 6 INCH BEADED FC 14X160MM STD BODY STD NECK (Item No. 00784301406); || i. VERSYS 6 INCH BEADED FC 15X160MM STD BODY STD NECK (Item No. 00784301506); || j. VERSYS 6 INCH BEADED FC 16X160MM STD BODY STD NECK (Item No. 00784301606); || k. VERSYS 6 INCH BEADED FC 17X160MM STD BODY STD NECK (Item No. 00784301706); || l. VERSYS 6 INCH BEADED FC 18X160MM STD BODY STD NECK (Item No. 00784301806); || m. VERSYS 6 INCH BEADED FC 18X160MM STD BODY EXT NECK (Item No. 00784301826); || n. VERSYS 6 INCH BEADED FC 19X160MM STD BODY EXT NECK (Item No. 00784301926); || o. VERSYS 6 INCH BEADED FC 20X160MM STD BODY STD NECK (Item No. 00784302006); || p. VERSYS 6 INCH BEADED FC 20X160MM STD BODY EXT NECK (Item No. 00784302026); || q. VERSYS 6 INCH BEADED FC 21X160MM STD BODY EXT NECK (Item No. 00784302126); || r. VERSYS 6 INCH BEADED FC 22X160MM STD BODY EXT NECK (Item No. 00784302226); || s. VERSYS 6 INCH BEADED FC 17X160MM LM BODY XEXT NECK (Item No. 00784301746); || t. VERSYS 6 INCH BEADED FC 17X160MM LM BODY EXT NECK (Item No. 00784301756 || u. VERSYS 6 INCH BEADED FC STEM 18X160MM LM (Item No. 00784301836); || v. VERSYS 6 INCH BEADED FC 18X160MM LM BODY XEXT NECK (Item No. 00784301846); || w. VERSYS 6 INCH BEADED FC 18X160MM LM BODY EXT NECK (Item No. 00784301856); || x. VERSYS 6 INCH BEADED FC 19X160MM LM BODY XEXT NECK (Item No. 00784301946); || y. VERSYS 6 INCH BEADED FC 19X160MM LM BODY EXT NECK (Item No. 00784301956); || z. VERSYS 6 INCH BEADED FC 20X160MM LM BODY XEXT NECK (Item No. 00784302046); || aa. VERSYS 6 INCH BEADED FC 20X160MM LM BODY EXT NECK (Item No. 00784302056); || ab. VERSYS 6 INCH BEADED FC 21X160MM LM BODY XEXT NECK (Item No. 00784302146); || ac. VERSYS 6 INCH BEADED FC 21X160MM LM BODY EXT NECK (Item No. 00784302156); || ad. VERSYS 6 INCH BEADED FC 22X160MM LM BODY XEXT NECK (Item No. 00784302246); || ae. VERSYS 6 INCH BEADED FC 22X160MM LM BODY EXT NECK (Item No. 00784302256) || Components of the system are intended to replace the proximal femur, mid-shaft femur, distal femur, proximal tibia, and/or total knee in cases that require extensive resection and restoration.
“The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.