NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System
Medical device recall Z-0319-2022. Published in FDA’s Enforcement Report on Dec 8, 2021.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 8, 2021. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- 47 states named in where it went
- Total 11,861 devices (IMLL=10,657 and Short=1,204) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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 PACKAGED END CAP, 8.5/ 10.7MM, +20MM CPA3-000 PA1052-000 PACKAGED END CAP, 12.5MM , +0MM CPA3-005 PA1052-005 PACKAGED END CAP, 12.5MM , +5MM CPA3-010 PA1052-010 PACKAGED END CAP, 12.5MM , +10MM CPA3-015 PA1052-015 PACKAGED END CAP, 12.5MM , +15MM CPA3-020 PA1052-020 PACKAGED END CAP, 12.5MM , +20MM HEC1-000 PA0709-000 END CAP, 0MM HUMERAL NAIL HEC2-000 PA0709-002 END CAP, 2MM HUMERAL NAIL HEC3-000 PA0709-005 END CAP, 5MM HUMERAL NAIL HEC4-000 PA0709-010 END CAP, 10MM HUMERAL NAIL HEC5-000 PA0709-015 END CAP, 15MM HUMERAL NAIL LSB3-020 PP1699-020 Locking Screw, 3.5mm x 2 0mm LSB3-025 PP1699-025 Locking Screw, 3.5mm x 2 5mm LSB3-030 PP1699-030 Locking Screw, 3.5mm x 3 0mm LSB3-035 PP1699-035 Locking Screw, 3.5mm x 3 5mm LSB3-040 PP1699-040 Locking Screw, 3.5mm x 4 0mm LSB3-045 PP1699-045 Locking Screw, 3.5mm x 4 5mm LSB3-050 PP1699-050 Locking Screw, 3.5mm x 5 0mm LSB3-055 PP1699-055 Locking Screw, 3.5mm x 5 5mm LSB3-060 PP1699-060 Locking Screw, 3.5mm x 6 0mm LSB3-200-S PA1220-020 3.5mm x 20mm Screw, Peg LSB3-250-S PA1220-025 3.5mm x 25mm Screw, Peg LSB3-300-S PA1220-030 3.5mm x 30mm Screw, Peg LSB3-350-S PA1220-035 3.5mm x 35mm Screw, Peg LSB3-400-S PA1220-040 3.5mm x 40mm Screw, Peg LSB3-450-S PA1220-045 3.5mm x 45mm Screw, Peg LSB3-500-S PA1220-050 3.5mm x 50mm Screw, Peg LSB3-550-S PA1220-055 3.5mm x 55mm Screw, Peg LSB3-600-S PA1220-060 3.5mm x 60mm Screw, Peg LSB4-020 PP1425-020 Locking Screw, 4.0mm x 20mm LSB4-025 PP1425-025 Locking Screw, 4.0mm x 25mm LSB4-030 PP1425-030 Locking Screw, 4.0mm x 30mm LSB4-035 PP1425-035 Locking Screw, 4.0mm x 35mm LSB4-040 PP1425-040 Locking Screw, 4.0mm x 40mm LSB4-045 PP1425-045 Locking Screw, 4.0mm x 45mm LSB4-050 PP1425-050 Locking Screw, 4.0mm x 50mm LSB4-055 PP1425-055 Locking Screw, 4.0mm x 55mm LSB4-060 PP1425-060 Locking Screw, 4.0mm x 60mm LSB5-020 PP1426-020 Locking Screw, 5.0mm x 20mm LSB5-025 PP1426-025 Locking Screw, 5.0mm x 25mm LSB5-030 PP1426-030 Locking Screw, 5.0mm x 30mm LSB5-035 PP1426-035 Locking Screw, 5.0mm x 35mm LSB5-040 PP1426-040 Locking Screw, 5.0mm x 40mm LSB5-045 PP1426-045 Locking Screw, 5.0mm x 45mm LSB5-050 PP1426-050 Locking Screw, 5.0mm x 50mm LSB5-055 PP1426-055 Locking Screw, 5.0mm x 55mm LSB5-060 PP1426-060 Locking Screw, 5.0mm x 60mm LSB5-065 PP1426-065 Locking Screw, 5.0mm x 65mm LSB5-070 PP1426-070 Locking Screw, 5.0mm x 70mm LSB5-075 PP1426-075 Locking Screw, 5.0mm x 75mm LSC4-020 PP1794-020 Locking Screw, 4.0mm x 2 0mm LSC4-025 PP1794-025 Locking Screw, 4.0mm x 2 5mm LSC4-030 PP1794-030 Locking Screw, 4.0mm x 3 0mm LSC4-035 PP1794-035 Locking Screw, 4.0mm x 3 5mm LSC4-040 PP1794-040 Locking Screw, 4.0mm x 4 0mm LSC4-045 PP1794-045 Locking Screw, 4.0mm x 4 5mm LSC4-050 PP1794-050 Locking Screw, 4.0mm x 5 0mm LSC4-055 PP1794-055 Locking Screw, 4.0mm x 5 5mm LSC4-060 PP1794-060 Locking Screw, 4.0mm x 6 0mm LSC4-200-S PA1221-020 4.0mm x 20mm Screw, Peg LSC4-250-S PA1221-025 4.0mm x 25mm Screw, Peg LSC4-300-S PA1221-030 4.0mm x 30mm Screw, Peg LSC4-350-S PA1221-035 4.0mm x 35mm Screw, Peg LSC4-400-S PA1221-040 4.0mm x 40mm Screw, Peg LSC4-450-S PA1221-045 4.0mm x 45mm Screw, Peg LSC4-500-S PA1221-050 4.0mm x 50mm Screw, Peg LSC4-550-S PA1221-055 4.0mm x 55mm Screw, Peg LSC4-600-S PA1221-060 4.0mm x 60mm Screw, Peg LSC5-020 PP1742-020 Locking Screw, 5.0mm x 2 0mm LSC5-025 PP1742-025 Locking Screw, 5.0mm x 2 5mm LSC5-030 PP1742-030 Locking Screw, 5.0mm x 3 0mm LSC5-035 PP1742-035 Locking Screw, 5.0mm x 3 5mm LSC5-040 PP1742-040 Locking Screw, 5.0mm x 4 0mm LSC5-045 P
Total 11,861 devices (IMLL=10,657 and Short=1,204), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,994 characters
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 LSB3-050 PP1699-050 Locking Screw, 3.5mm x 5 0mm 812258021405 LSB3-055 PP1699-055 Locking Screw, 3.5mm x 5 5mm 812258021412 LSB3-060 PP1699-060 Locking Screw, 3.5mm x 6 0mm 00887517029027 LSB3-200-S PA1220-020 3.5mm x 20mm Screw, Peg 00887517029010 LSB3-250-S PA1220-025 3.5mm x 25mm Screw, Peg 00887517029003 LSB3-300-S PA1220-030 3.5mm x 30mm Screw, Peg 00887517028990 LSB3-350-S PA1220-035 3.5mm x 35mm Screw, Peg 00887517028983 LSB3-400-S PA1220-040 3.5mm x 40mm Screw, Peg 00887517028976…
FDA’s list runs to 132,824 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, UAE, United Kingdom.
The states and territories these words name
47 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- Rhode Island
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 29, 2021.
- FDA classified it on Dec 1, 2021.
- FDA’s Enforcement Report published it on Dec 8, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- NuVasive Specialized Orthopedics, Inc., of Aliso Viejo, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 132,824 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.