Nuvasive Specialized Orthopedics Inc recalls NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transpor
Recalled Product
NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur Trochanter 10 Degree Bend Component of the orthopedic Precice Bone Transport System of intramedullary nail, locking screws, reusable instruments, and hand-held External Remote Controller (ERC).
Hazard / Issue
During explantation, standard removal tools can generate sufficient forces to cause distal plug to disassociate from the bone transport system.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Item Number: PA1160-10D400-7 Description: ANTE FEMUR TROCH 10DEG11.5MM X 400MM 7/10CM ST Lot/Serial Number: 9011815AAA 9021510AAA 9022225AAA 9072512AAA Item Number: PA1161-10D400-7 Description: ANTE FEMUR TROCH 10DEG13MM X 400MM, 7/10CM ST Lot/Serial Number: 9012506AAA 9061720AAA Item Number: PA1160-10SJ360-7 Description: ANTE TIBIA 10DEG, 3-HOLE11.5MM X 360MM 7/10CM ST Lot/Serial Number: 9013007AAA 9030706AAA 9031514AAA 9042208AAA 9050811AAA 9072218AAA Item Number: PA1159-10SJ360-7 Description: ANTE TIBIA 10DEG, 3-HOLE10MM X 360MM, 7/10CM STK Lot/Serial Number: 9020607AAA 9022815AAA 9050211AAA 9071604AAA Item Number: PA1160-90SJ340-7 Description: ANTE TIBIA 10DEG, 3-HOLE11.5MM X 340MM, 7/9CM ST Lot/Serial Number: 9020608AAA 9052110AAA 9052906AAA 9072217AAA Item Number: PA1160-80SJ320-7 Description: ANTE TIBIA 10DEG, 3-HOLE11.5MM X 320MM, 7/8CM ST Lot/Serial Number: 9021222AAA Item Number: PA1159-80SJ320-7 Description: ANTE TIBIA 10DEG, 3-HOLE10MM X 320MM, 7/8CM STK Lot/Serial Number: 9021223AAA Item Number: PA1160-70SJ300-7 Description: ANTE TIBIA 10DEG, 3-HOLE11.5MM X 300MM, 7/7CM ST Lot/Serial Number: 9021224AAA Item Number: PA1160-10D380-7 Description: ANTE FEMUR TROCH 10DEG11.5MM X 380MM 7/10CM ST Lot/Serial Number: 9021512AAA 9072513AAA 9072912AAA 9080106AAA Item Number: PA1159-90SJ340-7 Description: ANTE TIBIA 10DEG, 3-HOLE10MM X 340MM, 7/9CM STK Lot/Serial Number: 9020609AAA 9052208AAA 9071603AAA Item Number: PA1161-10X380-7 Description: RETRO FEMUR STRAIGHT13MM X 380MM, 7/10CM ST Lot/Serial Number: 9021913AAA Item Number: PA1160-10X360-7 Description: RETRO FEMUR STRAIGHT11.5MM X 360MM, 7/10CM ST Lot/Serial Number: 9022227AAA Item Number: PA1161-10X360-7 Description: RETRO FEMUR STRAIGHT13MM X 360MM, 7/10CM ST Lot/Serial Number: 9022226AAA Item Number: PA1160-10SJ400-7 Description: ANTE TIBIA 10DEG, 3-HOLE11.5MM X 400MM 7/10CM ST Lot/Serial Number: 9020809AAA Item Number: PA1159-10SJ400-7 Description: ANTE TIBIA 10DEG, 3-HOLE10MM X 400MM, 7/10CM STK Lot/Serial Number: 9020810AAA Item Number: PA1160-10SJ380-7 Description: ANTE TIBIA 10DEG, 3-HOLE11.5MM X 380MM 7/10CM ST Lot/Serial Number: 9022813AAA 9042506AAA Item Number: PA1160-10B380-7 Description: ANTE FEMUR PIRIFOMIS11.5MM X 380MM 7/10CM ST Lot/Serial Number: 9021513AAA Item Number: PA1160-10B360-7 Description: ANTE FEMUR PIRIFOMIS11.5MM X 360MM 7/10CM ST Lot/Serial Number: 9021514AAA Item Number: PA1159-10SJ380-7 Description: ANTE TIBIA 10DEG, 3-HOLE10MM X 380MM, 7/10CM STK Lot/Serial Number: 9031310AAA 9071605AAA Item Number: PA1160-10D360-7 Description: ANTE FEMUR TROCH 10DEG11.5MM X 360MM 7/10CM ST Lot/Serial Number: 9022816AAA Item Number: PA1160-60SJ280-6 Description: ANTE TIBIA 10DEG, 3-HOLE11.5MM X 280MM, 6/6CM ST Lot/Serial Number: 9021914AAA Item Number: PA1159-70SJ300-7 Description: ANTE TIBIA 10DEG, 3-HOLE10MM X 300MM, 7/7CM STK Lot/Serial Number: 9021915AAA Item Number: PA1160-90X340-7 Description: RETRO FEMUR STRAIGHT11.5MM X 340MM, 7/9CM ST Lot/Serial Number: 9041617AAA Item Number: PA1160-10X380-7 Description: RETRO FEMUR STRAIGHT11.5MM X 380MM 7/10CM ST Lot/Serial Number: 9041618AAA Item Number: PA1159-10D380-7 Description: ANTE FEMUR TROCH 10DEG10MM X 380MM, 7/10CM STK Lot/Serial Number: 9042211AAA Item Number: PA1161-10B380-7 Description: ANTE FEMUR PIRIFOMIS13MM X 380MM, 7/10CM ST Lot/Serial Number: 9052305AAA 9061009AAA Item Number: PA1161-10B400-7 Description: ANTE FEMUR PIRIFOMIS13MM X 400MM, 7/10CM ST Lot/Serial Number: 9052306AAA Item Number: PA1160-10B400-7 Description: ANTE FEMUR PIRIFOMIS11.5MM X 400MM 7/10CM ST Lot/Serial Number: 9053110AAA Item Number: PA1160-10X400-7 Description: RETRO FEMUR STRAIGHT11.5MM X 400MM 7/10CM ST Lot/Serial Number: 9061208AAA Item Number: PA1161-10X400-7 Description: RETRO FEMUR STRAIGHT13MM X 400MM, 7/10CM ST Lot/Serial Number: 9061209AAA Item Number: PA1161-10B400-7 Description: ANTE FEMUR PIRIFOMIS13MM X 400MM, 7/10CM ST Lot/Serial Number: 9061008AAA Item Number: PA1159-80X320-7 Description: RETO FEMUR STRAIGHT10MM X 320MM, 7/8CM STK Lot/Serial Number: 9062416AAA Item Number: PA1161-10D380-7 Description: ANTE FEMUR TROCH 10DEG13MM X 380MM, 7/10CM ST Lot/Serial Number: 9061721AAA 9071825AAA Item Number: PA1159-10B400-7 Description: ANTE FEMUR PIRIFORMIS10MM X 400MM, 7/10CM STK Lot/Serial Number: 9072219AAA Item Number: PA1159-10D400-7 Description: ANTE FEMUR TROCH 10DEG10MM X 400MM, 7/10CM STK Lot/Serial Number: 9072220AAA 9072911AAA Item Number: PA1159-10B380-7 Description: ANTE FEMUR PIRIFORMIS10MM X 380MM, 7/10CM STK Lot/Serial Number: 9072221AAA
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