NUVASIVE PRECICE Limb Lengthening System: Updated Instructions Clarify Patient Selection
NuVasive is updating instructions for the PRECICE limb lengthening implant system to clarify it is for patients 18 years or older weighing 50 lbs or more, with no more than two devices implanted at a time.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported adverse events or injuries. The recall is voluntary and instructional in nature, updating patient selection criteria to prevent inappropriate use. Per the rubric, voluntary precautionary labeling recalls without reported harm are classified as Moderate.
Plain-English summary
The PRECICE Intramedullary Limb Lengthening (IMLL) and Short System, manufactured by NuVasive Specialized Orthopedics, Inc., is a surgical implant used for limb lengthening procedures. A total of 11,861 devices distributed worldwide are subject to this recall.
NuVasive is updating the Instructions for Use to clarify three patient selection requirements: the device is intended only for patients 18 years of age or older, patients must weigh at least 50 lbs during treatment, and no more than two devices should be implanted at one time. These clarifications are intended to ensure the device is used only in appropriate patient populations as originally designed.
The PRECICE system has been distributed throughout the United States and to more than 30 countries internationally since April 2015. Patients and physicians should consult the updated Instructions for Use to confirm compliance with these usage parameters.
Patients with questions about their treatment should contact their healthcare provider. Healthcare providers should ensure all patients meet these criteria before implantation.
The recalled product
- Product
- 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 PA1
- Manufacturer
- NuVasive Specialized Orthopedics, Inc.
- Hazard
- off-label-use
- patient-selection-error
- device-overuse
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 8.5/ 10.7MM
- +0MM 887517001146 CPA2-005 PA1051-005 PACKAGED END CAP
- +5MM 887517001153 CPA2-010 PA1051-010 PACKAGED END CAP
- +10MM 887517001160 CPA2-015 PA1051-015 PACKAGED END CAP
- +15MM 887517001177 CPA2-020 PA1051-020 PACKAGED END CAP
- +20MM 887517001184 CPA3-000 PA1052-000 PACKAGED END CAP
- 12.5MM
- +0MM 887517001191 CPA3-005 PA1052-005 PACKAGED END CAP
- +5MM 887517001207 CPA3-010 PA1052-010 PACKAGED END CAP
- +10MM 887517001214 CPA3-015 PA1052-015 PACKAGED END CAP
- +15MM 887517001221 CPA3-020 PA1052-020 PACKAGED END CAP
- +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
Distribution
Distributed in 46 states:
- 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
- RI
- SC
- TN
- TX
- UT
- VA
- WA
- WI
- WV
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