FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1. FLS - Foot Locking Plates System, Cancellous Stabilization Screw; Article Numbers: 37303-10, 37303-12, 37303-14, 37303-16, 37303-18, 37303-20, 37303-22, 37303-24, 37303-26, 37303-28, 37303-30. 2. FLS - Foot Locking Plates System, Cortical Screw; Article Numbers: 32271-10, 32271-12, 32271-14, 32271-16, 32271-18, 32271-20, 32271-22, 32271-24, 32271-26, 32271-28, 32271-32, 32271-34. 3. FLS - Foot Locking Plates System, Cortical Stabilization Screw; Article Numbers: 37304-10, 37304-12, 37304-14, 37304-16, 37304-18, 37304-20, 37304-22, 37304-24. 4. FLS - Foot Locking Plates System, FLS Plate, Curved; Article Numbers: 21413-6. 5. FLS - Foot Locking Plates System, FLS Plate, H-Shape; Article Numbers: 21431-ME. 6. FLS - Foot Locking Plates System, FLS Plate, L-Shape; Article Numbers: 21482, 21483. 7. FLS - Foot Locking Plates System, FLS Plate, Straight; Article Numbers: 21421-5. 8. FLS - Foot Locking Plates System, Stabilization Screw; Article Numbers: 37241-10, 37241-12, 37241-14, 37241-16, 37241-18, 37241-20, 37241-22, 37241-24, 37241-26, 37241-28, 37241-30. 9. HOL - Hallux Osteotomy Locking Plate, Hallux Osteotomy Plate; Article Numbers: 21015-08, 21015-09.

Detalles del retiro

Fabricante

I.T.S. GmbH

Distribuidor

US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.

Lote

1. Article Number (Lot Numbers): 37303-10 (18/151720, 18/268729, 679/032432, 679/072268, 679/102237, 679/102307), 37303-12 (18/570637, 679/032434, 679/072269, 679/102346, 679/112227), 37303-14 (18/751091, 26/F66913, 679/012510, 679/062288, 679/102359, 679/112410), 37303-16 (679/072263, 679/102245, 18/151841, 26/F66914, 18/331193, 18/543625, 679/012511, 679/042403, 679/102360), 37303-18 (18/151942, 18/210467, 18/231415, 18/341194, 18/572633, 18/771093, 679/012512, 679/022507, 679/042404, 679/102248, 679/112319), 37303-20 (18/152043, 18/211468, 18/351195, 18/573634, 18/701585, 18/781094, 679/022508, 679/042420, 679/112216, 679/112328), 37303-22 (18/171705, 18/212469, 18/361196, 18/574635, 18/791095, 679/022509, 679/042417, 679/112224, 679/112340), 37303-24 (18/575639, 18/741572, 26/F66915, 679/022510, 679/112226, 679/122313, 679/122333), 37303-26 (18/152346, 18/214471, 26/F66916, 679/012403, 679/112230, 679/122323), 37303-28 (26/F66917, 679/112231, 679/122328), 37303-30 (18/192716, 18/591743, 679/122334). 2. Article Number (Lot Numbers): 32271-10 (18/061949, 18/231167, 679/062351), 32271-12 (18/048927, 26/F66235, 679/042215, 679/062342, 679/062405, 679/062489, 679/072271), 32271-14 (18/049928, 18/231165, 26/F66140, 679/042210, 679/052340, 679/052518, 679/062471, 679/062490, 679/072267), 32271-16 (18/231164, 18/311125, 26/F66141, 679/042216, 679/052519, 679/062315, 679/062483, 679/072272, 679/072401), 32271-18 (18/062950, 26/F65556, 26/F66236, 679/032261, 679/062332, 679/072402), 32271-20 (18/063951, 26/F66237, 679/052326), 32271-22 (18/064952, 26/F65557, 679/032263, 679/062354), 32271-24 (18/065953, 26/F65558, 679/062333), 32271-26 (679/032265), 32271-28 (26/F65559, 679/062357, 679/052520), 32271-32 (26/F65561), 32271-34 (26/F65562). 3. Article Number (Lot Numbers): 37304-10 (18/635486, 26/F24799, 679/012419, 86/011176), 37304-12 (18/061352, 18/521172, 18/5211721, 18/576643, 18/630487, 679/012433, 679/092207, 679/122409), 37304-14 (18/081360, 18/531173, 18/5311731, 18/577644, 18/631488, 679/012434, 679/092208, 679/122410), 37304-16 (18/541174, 18/578645, 18/632489, 679/012444, 679/092201, 679/122411), 37304-18 (18/092020, 18/551175, 18/633490, 679/022403, 679/092202), 37304-20 (18/011320, 18/561176, 18/634491, 679/012287, 679/012420, 679/082217, 86/483331), 37304-22 (18/241273, 679/012288, 679/012421), 37304-24 (18/021321, 18/571177, 679/012289, 679/012445). 4. Article Number (Lot Numbers): 21413-6 (26/F52124). 5. Article Number (Lot Numbers): 21431-ME (679/102045). 6. Article Number (Lot Numbers): 21482 (679/092020), 21483 (26/F55902). 7. Article Number (Lot Numbers): 21421-5 (26/F65377, 679/092039). 8. Article Number (Lot Numbers): 37241-10 (18/012169, 18/610104, 18/701013), 37241-12 (18/231295, 18/767108), 37241-14 (18/511016, 18/537392, 26/F24807, 679/012280), 37241-16 (18/005340, 18/121106, 18/231387, 18/521017, 18/560517), 37241-18 (18/232328, 18/531018, 679/072408, 86/311848), 37241-20 (18/233388, 18/541020, 18/562519, 679/072419, 86/287847), 37241-22 (18/066109, 18/234389, 18/551021, 26/F24594, 26/F24811), 37241-24 (18/561022, 18/564521, 18/608110, 26/F24595), 37241-26 (18/611111, 18/711023, 26/F24596, 26/F24813), 37241-28 (18/612112, 18/721024, 18/811597, 26/F24597, 86/485508), 37241-30 (18/015172, 18/613113, 18/731019, 26/F24598). 9. Article Number (Lot Numbers): 21015-08 (00/0123-12, 00/0321-43, 00/0723-07), 21015-09 (00/0123-13).

Clasificación de riesgo

Class II

Área (FDA)

device

País

Austria