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Class 2 Device Recall Precice Bone Transport Nail |
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Date Initiated by Firm |
July 24, 2020 |
Create Date |
October 07, 2020 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0069-2021 |
Recall Event ID |
86150 |
510(K)Number |
K201567 K193016
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Product Classification |
Rod, fixation, intramedullary and accessories - Product Code HSB
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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). |
Code Information |
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 |
Recalling Firm/ Manufacturer |
Nuvasive Specialized Orthopedics Inc 101 Enterprise Ste 100 Aliso Viejo CA 92656-2604
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For Additional Information Contact |
Matt Collins 720-450-4668
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Manufacturer Reason for Recall |
During explantation, standard removal tools can generate sufficient forces to cause distal plug to disassociate from the bone transport system.
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FDA Determined Cause 2 |
Device Design |
Action |
On 7/28/2020, the firm sent a "Field Safety Notice" to US and OUS Surgeons, and Distributors via email informing them of an update removal/explantation process and reminding them to follow the Instructions for Use. Customers are instructed to:
-Review, complete, sign (via DocuSign) and return the Consignee Confirmation Form that is accompanying the notification. Directions are located on the form.
-Make sure Instruction for Use are followed
-Forward the notice to anyone in their facility that needs to be informed.
Any questions or assistance that is needed, customers are instructed to contact the Recalling Firm at complaints@nuvasive.com.
On 8/6/2020, the firm sent a revised/updated "URGENT FIELD SAFETY NOTICE" to US and OUS Surgeons and Distributors via email informing them of that the internal components of the Bone Transport Nail may remain in the patient, which may lead to a revision surgery. In addition, if adverse reactions or quality problems are experienced with the use of the affected product, customers should report the adverse event to FDA's MedWatch Adverse Event Reporting program online at www.fda.gov, by regular mail to: MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20853 or by fax at 800-332-0178. |
Quantity in Commerce |
41 total units |
Distribution |
Worldwide distribution. US nationwide, Austria, Australia, Canada, Switzerland, Denmark, Spain, France, United Kingdom, Germany, UAE, Luxembourg, Israel, Netherlands. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = HSB and Original Applicant = NuVasive Specialized Orthopedics, Inc.
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