Reported Oct 14, 2020 · Ongoing
NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur Trochanter 10 Degree Bend Component of…
Nuvasive Specialized Orthopedics Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nuvasive Specialized Orthopedics Inc · 101 Enterprise Ste 100 · Aliso Viejo, CA · 92656-2604
Is this the product you have?
- 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).
- Lot codes and dates
36 of 36 products
Products covered by this recall Model / number Product as published PA1160-10D400-7Description: ANTE FEMUR TROCH 10DEG11.5MM X 400MM 7/10CM ST Lot/Serial Number: 9011815AAA 9021510AAA 9022225AAA 9072512AAA PA1161-10D400-7Description: ANTE FEMUR TROCH 10DEG13MM X 400MM, 7/10CM ST Lot/Serial Number: 9012506AAA 9061720AAA PA1160-10SJ360-7Description: ANTE TIBIA 10DEG, 3-HOLE11.5MM X 360MM 7/10CM ST Lot/Serial Number: 9013007AAA 9030706AAA 9031514AAA 9042208AAA 9050811AAA 9072218AAA PA1159-10SJ360-7Description: ANTE TIBIA 10DEG, 3-HOLE10MM X 360MM, 7/10CM STK Lot/Serial Number: 9020607AAA 9022815AAA 9050211AAA 9071604AAA PA1160-90SJ340-7Description: ANTE TIBIA 10DEG, 3-HOLE11.5MM X 340MM, 7/9CM ST Lot/Serial Number: 9020608AAA 9052110AAA 9052906AAA 9072217AAA PA1160-80SJ320-7Description: ANTE TIBIA 10DEG, 3-HOLE11.5MM X 320MM, 7/8CM ST Lot/Serial Number: 9021222AAA PA1159-80SJ320-7Description: ANTE TIBIA 10DEG, 3-HOLE10MM X 320MM, 7/8CM STK Lot/Serial Number: 9021223AAA PA1160-70SJ300-7Description: ANTE TIBIA 10DEG, 3-HOLE11.5MM X 300MM, 7/7CM ST Lot/Serial Number: 9021224AAA PA1160-10D380-7Description: ANTE FEMUR TROCH 10DEG11.5MM X 380MM 7/10CM ST Lot/Serial Number: 9021512AAA 9072513AAA 9072912AAA 9080106AAA PA1159-90SJ340-7Description: ANTE TIBIA 10DEG, 3-HOLE10MM X 340MM, 7/9CM STK Lot/Serial Number: 9020609AAA 9052208AAA 9071603AAA PA1161-10X380-7Description: RETRO FEMUR STRAIGHT13MM X 380MM, 7/10CM ST Lot/Serial Number: 9021913AAA PA1160-10X360-7Description: RETRO FEMUR STRAIGHT11.5MM X 360MM, 7/10CM ST Lot/Serial Number: 9022227AAA PA1161-10X360-7Description: RETRO FEMUR STRAIGHT13MM X 360MM, 7/10CM ST Lot/Serial Number: 9022226AAA PA1160-10SJ400-7Description: ANTE TIBIA 10DEG, 3-HOLE11.5MM X 400MM 7/10CM ST Lot/Serial Number: 9020809AAA PA1159-10SJ400-7Description: ANTE TIBIA 10DEG, 3-HOLE10MM X 400MM, 7/10CM STK Lot/Serial Number: 9020810AAA PA1160-10SJ380-7Description: ANTE TIBIA 10DEG, 3-HOLE11.5MM X 380MM 7/10CM ST Lot/Serial Number: 9022813AAA 9042506AAA PA1160-10B380-7Description: ANTE FEMUR PIRIFOMIS11.5MM X 380MM 7/10CM ST Lot/Serial Number: 9021513AAA PA1160-10B360-7Description: ANTE FEMUR PIRIFOMIS11.5MM X 360MM 7/10CM ST Lot/Serial Number: 9021514AAA PA1159-10SJ380-7Description: ANTE TIBIA 10DEG, 3-HOLE10MM X 380MM, 7/10CM STK Lot/Serial Number: 9031310AAA 9071605AAA PA1160-10D360-7Description: ANTE FEMUR TROCH 10DEG11.5MM X 360MM 7/10CM ST Lot/Serial Number: 9022816AAA - Amount recalled
- 41 total units
Where it was sold
- Nationwide
Why it was recalled
During explantation, standard removal tools can generate sufficient forces to cause distal plug to disassociate from the bone transport system.
This product could cause temporary or reversible health problems — stop using it.
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