Recall Z-0319-2022 ยท HSB Rod, Fixation, Intramedullary And Accessories
NuVasive Specialized Orthopedics, Inc.
NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model Number/Item Number/Product Description: CPA1-000 PA0382-001 End Cap CPA2-000 PA1051-000 PACKAGED END CAP, 8.5/ 10.7MM, +0MM CPA2-005 PA1051-005 PACKAGED END CAP, 8.5/ 10.7MM, +5MM CPA2-010 PA1051-010 PACKAGED END CAP, 8.5/ 10.7MM, +10MM CPA2-015 PA1051-015 PACKAGED END CAP, 8.5/ 10.7MM, +15MM CPA2-020 PA1051-020 PAC
| Date | Dec 1, 2021 (initiated Oct 29, 2021) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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 |
| Quantity | 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, and WV. O.U.S.: Argentina, Australia, Austria, Belgium, Canada, Colombia, Chile, Cyprus, Denmark, F |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101997 | ELLIPSE INTRAMEDULLARY LIMB LENGTHENING SYSTEM Ellipse Technologies, Inc., Jul 12, 2011 |
| K113695 | ELLIPSE PRECICE TRAUMA NAIL SYSTEM Ellipse Technologies, Inc., Mar 28, 2012 |
| K141739 | RESIDUAL LIMB LENGTHENING SYSTEM Ellipse Technologies, Inc., Oct 7, 2014 |
| K151131 | PRECICE Intramedullary Limb Lengthening System Ellipse Technologies, Incorporated, Jun 19, 2015 |