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,
Check against the official notice below — it lists the full affected range.
NuVasive Specialized Orthopedics is recalling approximately 11,861 PRECICE Intramedullary Limb Lengthening (IMLL) and Short System devices distributed across the United States, Puerto Rico, and multiple countries worldwide. The recall affects devices manufactured between April 2015 and February 2021. The company has updated the Instructions for Use to clarify that the device is intended only for patients 18 years and older, that patients must weigh 50 pounds or more during treatment, and that no more than two devices should be implanted at the same time.
The recall document does not specify what action affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. 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, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Jordan, Luxemburg, Mexico, Quantity: Total 11,861 devices (IMLL=10,657 and Short=1,204) Lot/code info: All Lots manufactured between April 2015 to February 2021 UDI/Model No./Item No./Product Description: 812258020002 CPA1-000 PA0382-001 End Cap 887517001139 CPA2-000 PA1051-000 PACKAGED END CAP, 8.5/ 10.7MM, +0MM 887517001146 CPA2-005 PA1051-005 PACKAGED END CAP, 8.5/ 10.7MM, +5MM 887517001153 CPA2-010 PA1051-010 PACKAGED END CAP, 8.5/ 10.7MM, +10MM 887517001160 CPA2-015 PA1051-015 PACKAGED END CAP, 8.5/ 10.7MM, +15MM 887517001177 CPA2-020 PA1051-020 PACKAGED END CAP, 8.5/ 10.7MM, +20MM 887517001184 CPA3-000 PA1052-000 PACKAGED END CAP, 12.5MM , +0MM 887517001191 CPA3-005 PA1052-005 PACKAGED END CAP, 12.5MM , +5MM 887517001207 CPA3-010 PA1052-010 PACKAGED END CAP, 12.5MM , +10MM 887517001214 CPA3-015 PA1052-015 PACKAGED END CAP, 12.5MM , +15MM 887517001221 CPA3-020 PA1052-020 PACKAGED END CAP, 12.5MM , +20MM 812258028121 HEC1-000 PA0709-000 END CAP, 0MM HUMERAL NAIL 812258028138 HEC2-000 PA0709-002 END CAP, 2MM HUMERAL NAIL 812258028145 HEC3-000 PA0709-005 END CAP, 5MM HUMERAL NAIL 812258028152 HEC4-000 PA0709-010 END CAP, 10MM HUMERAL NAIL 812258028169 HEC5-000 PA0709-015 END CAP, 15MM HUMERAL NAIL 812258021337 LSB3-020 PP1699-020 Locking Screw, 3.5mm x 2 0mm 812258021344 LSB3-025 PP1699-025 Locking Screw, 3.5mm x 2 5mm 812258021351 LSB3-030 PP1699-030 Locking Screw, 3.5mm x 3 0mm 812258021368 LSB3-035 PP1699-035 Locking Screw, 3.5mm x 3 5mm 812258021375 LSB3-040 PP1699-040 Locking Screw, 3.5mm x 4 0mm 812258021382 LSB3-045 PP1699-045 Locking Screw, 3.5mm x 4 5mm 812258021399
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.