NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model Number/Item Number/Product Description

FDA device recall Z-0319-2022 · posted 2021-12-01 · Open, Classified

Recall details

Recalling firm

NuVasive Specialized Orthopedics, Inc.

Reason for recall

The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That patients should weigh 50 lbs. or more while undergoing treatment, and (3) That no more than two devices should be implanted at a time.

Action taken

On 11/01/2021, the firm emailed an "URGENT FIELD SAFETY NOTICE" to customers as a follow-up from it February and April 2021 communications. This notice informs of updates to the U.S. IFU which includes: a. Clarifying that - The PRECICE Intramedullary Limb Lengthening System is intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones in adults. b. Warnings - Patients of the PRECICE Intramedullary Limb Lengthening System should not be implanted with more than two devices at a time, and the patient s weight should be a minimum of 50 lbs. These updates clarify the instructions regarding the target patient population based on the latest scientific evidence. Recommended User Actions: 1)The IFU should be consulted on an ongoing basis before and throughout patient treatment. 2)A Recalling Firm representative will be contacting their office to help with any questions or concerns. 3)Acknowledgement of these changes is critical. Review, complete, sign and return the attached Consignee Confirmation Form in accordance with the directions on the form. 4)Precice IMLL System Devices, for patients currently weighing less than 50 pounds and/or with more than two devices implanted should consult their healthcare team for assessment of their treatment progression and consider removal of nails promptly at the end of treatment. Following this recommended action can minimize the potential for implantation risks while also minimizing the risks associated with repetitive surgical interventions and sub-optimal conversion to alternative therapies mid-treatment. Any questions or assistance, contact at email FSNprecice@nuvasive.com or Sr. Dir, Global Quality (858)336-3421 Updated 04/04/2022 - Expansion of Recall to include Precice Uyte and Precice Freedom devices: An "URGENT FIELD SAFETY NOTICE" was emailed on 12/01/2021, to inform customers of two additional device systems included in this recall

Root cause

Device Design

Status

Open, Classified

Product code

HSB

Quantity affected

Total 11,861 devices (IMLL=10,657 and Short=1,204)

Distribution

U.S.: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT, VA, WA, WI, a

Date initiated

2021-10-29

Date posted

2021-12-01

Location

Aliso Viejo, CA

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