CLASS II ONGOING Device recall · Reported 7 Apr 2021 · FDA Enforcement Report
Precice Plate recalled by Nuvasive Specialized
Nuvasive Specialized Orthopedics is recalling Precice Plate, distributed nationwide in the US. The recall was initiated on 12 Feb 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1325-2021
- FDA event ID
- 87352
- Recalling firm
- Nuvasive Specialized Orthopedics, Aliso Viejo, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Feb 2021
- FDA classified
- 30 Mar 2021
- Reported
- 7 Apr 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 12 Feb 2021 | Recall initiated by company | |
| 30 Mar 2021 | Classified by FDA | +46 days |
| 7 Apr 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.
Product as listed by the FDA
PRECICE PLATE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
Where it was distributed
Worldwide distribution - U.S. Nationwide distribution and the countries of Argentina, Austria, Belgium, Canada, Chile, Colombia, Cyprus, Denmark, Finland, France, Germany, Greece, Hong Kong, Israel, Italy, Luxemburg, Netherlands, Portugal, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey and UAE. Consignee List provided only includes email addresses. Complete contact information is pending.
Questions about this recall
Why was it recalled?
Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.
Which lots are affected?
All Lots affected. Below are: Primary DI Number(GTIN)/Product Code (REF)/Product Description: 00887517021915 LP4.5-DLF30 PRECICE Plate 4.5mm Distal Femur Plate, Left, 35mm, 0-Hole; 00887517021908 LP4.5-DLF31 PRECICE Plate 4.5mm Distal Femur Plate, Left, 35mm, 1-Hole; 00887517021892 LP4.5-DLF32 PRECICE Plate 4.5mm Distal Femur Plate, Left, 35mm, 2-Hole; 00887517021885 LP4.5-DLF3B PRECICE Plate 4.5mm Distal Femur Plate, Left, 35mm, Bump; 00887517021878 LP4.5-DLF40 PRECICE Plate 4.5mm Distal Femur Plate, Left, 45mm, 0-Hole; 00887517021861 LP4.5-DLF41 PRECICE Plate 4.5mm Distal Femur Plate, Left, 45mm, 1-Hole; 00887517021854 LP4.5-DLF42 PRECICE Plate 4.5mm Distal Femur Plate, Left, 45mm, 2-Hole; 00887517021847 LP4.5-DLF4B PRECICE Plate 4.5mm Distal Femur Plate, Left, 45mm, Bump; 00887517021830 LP4.5-DRF30 PRECICE Plate 4.5mm Distal Femur Plate, Right, 35mm, 0-Hole; 00887517021823 LP4.5-DRF31 PRECICE Plate 4.5mm Distal Femur Plate, Right, 35mm, 1-Hole; 00887517021816 LP4.5-DRF32 PRECICE Plate 4.5mm Distal Femur Plate, Right, 35mm, 2-Hole; 00887517021809 LP4.5-DRF3B PRECICE Plate 4.5mm Distal Femur Plate, Right, 35mm, Bump; 00887517021793 LP4.5-DRF40 PRECICE Plate 4.5mm Distal Femur Plate, Right, 45mm, 0-Hole; 00887517021786 LP4.5-DRF41 PRECICE Plate 4.5mm Distal Femur Plate, Right, 45mm, 1-Hole; 00887517021779 LP4.5-DRF42 PRECICE Plate 4.5mm Distal Femur Plate, Right, 45mm, 2-Hole; 00887517021762 LP4.5-DRF4B PRECICE Plate 4.5mm Distal Femur Plate, Right, 45mm, Bump; 00887517021755 LP4.5-MLT30 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 35mm, 0-Hole; 00887517021748 LP4.5-MLT31 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 35mm, 1-Hole; 00887517021731 LP4.5-MLT32 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 35mm, 2-Hole; 00887517021724 LP4.5-MLT3B PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 35mm, Bump; 00887517021717 LP4.5-MLT40 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 45mm, 0-Hole; 00887517021700 LP4.5-MLT41 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 45mm, 1-Hole; 00887517021694 LP4.5-MLT42 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 45mm, 2-Hole; 00887517021687 LP4.5-MLT4B PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 45mm, Bump; 00887517021670 LP4.5-MRT30 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 35mm, 0-Hole; 00887517021663 LP4.5-MRT31 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 35mm, 1-Hole; 00887517021656 LP4.5-MRT32 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 35mm, 2-Hole; 00887517021649 LP4.5-MRT3B PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 35mm, Bump; 00887517021632 LP4.5-MRT40 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 45mm, 0-Hole; 00887517021625 LP4.5-MRT41 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 45mm, 1-Hole; 00887517021618 LP4.5-MRT42 PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 45mm, 2-Hole; 00887517021601 LP4.5-MRT4B PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 45mm, Bump; 00887517021595 LP4.5-PLF30 PRECICE Plate 4.5mm Proximal Femur Plate, Left, 35mm, 0-Hole; 00887517021588 LP4.5-PLF31 PRECICE Plate 4.5mm Proximal Femur Plate, Left, 35mm, 1-Hole; 00887517021571 LP4.5-PLF32 PRECICE Plate 4.5mm Proximal Femur Plate, Left, 35mm, 2-Hole; 00887517021564 LP4.5-PLF3B PRECICE Plate 4.5mm Proximal Femur Plate, Left, 35mm, Bump; 00887517021557 LP4.5-PLF40 PRECICE Plate 4.5mm Proximal Femur Plate, Left, 45mm, 0-Hole; 00887517021540 LP4.5-PLF41 PRECICE Plate 4.5mm Proximal Femur Plate, Left, 45mm, 1-Hole; 00887517021533 LP4.5-PLF42 PRECICE Plate 4.5mm Proximal Femur Plate, Left, 45mm, 2-Hole; 00887517021526 LP4.5-PLF4B PRECICE Plate 4.5mm Proximal Femur Plate, Left, 45mm, Bump; 00887517021519 LP4.5-PLT30 PRECICE Plate 4.5mm Proximal Tibia Plate, Left, 35mm, 0-Hole; 00887517021502 LP4.5-PLT31 PRECICE Plate 4.5mm Proximal Tibia Plate, Left, 35mm, 1-Hole; 00887517021496 LP4.5-PLT32 PRECICE Plate 4.5mm Proximal Tibia Plate, Left, 35mm, 2-Hole; 00887517021489 LP4.5-PLT3B PRECICE Plate 4.5mm Proximal Tibia Plate, Left, 35mm, Bump; 00887517021472 LP4.5-PLT40 PRECICE Plate 4.5mm Proximal Tibia Plate, Left, 45mm, 0-Hole; 00887517021465 LP4.5-PLT41 PRECICE Plate 4.5mm Proximal Tibia Plate, Left, 45mm, 1-Hole; 00887517021458 LP4.5-PLT42 PRECICE Plate 4.5mm Proximal Tibia Plate, Left, 45mm, 2-Hole; 00887517021441 LP4.5-PLT4B PRECICE Plate 4.5mm Proximal Tibia Plate, Left, 45mm, Bump; 00887517021434 LP4.5-PRF30 PRECICE Plate 4.5mm Proximal Femur Plate, Right, 35mm, 0-Hole; 00887517021427 LP4.5-PRF31 PRECICE Plate 4.5mm Proximal Femur Plate, Right, 35mm, 1-Hole; 00887517021410 LP4.5-PRF32 PRECICE Plate 4.5mm Proximal Femur Plate, Right, 35mm, 2-Hole; 00887517021403 LP4.5-PRF3B PRECICE Plate 4.5mm Proximal Femur Plate, Right, 35mm, Bump; 00887517021397 LP4.5-PRF40 PRECICE Plate 4.5mm Proximal Femur Plate, Right, 45mm, 0-Hole; 00887517021380 LP4.5-PRF41 PRECICE Plate 4.5mm Proximal Femur Plate, Right, 45mm, 1-Hole; 00887517021373 LP4.5-PRF42 PRECICE Plate 4.5mm Proximal Femur Plate, Right, 45mm, 2-Hole; 00887517021366 LP4.5-PRF4B PRECICE Plate 4.5mm Proximal Femur Plate, Right, 45mm, Bump; 00887517021359 LP4.5-PRT30 PRECICE Plate 4.5mm Proximal Tibia Plate, Right, 35mm, 0-Hole; 00887517021342 LP4.5-PRT31 PRECICE Plate 4.5mm Proximal Tibia Plate, Right, 35mm, 1-Hole; 00887517021335 LP4.5-PRT32 PRECICE Plate 4.5mm Proximal Tibia Plate, Right, 35mm, 2-Hole; 00887517021328 LP4.5-PRT3B PRECICE Plate 4.5mm Proximal Tibia Plate, Right, 35mm, Bump; 00887517021311 LP4.5-PRT40 PRECICE Plate 4.5mm Proximal Tibia Plate, Right, 45mm, 0-Hole; 00887517021304 LP4.5-PRT41 PRECICE Plate 4.5mm Proximal Tibia Plate, Right, 45mm, 1-Hole; 00887517021298 LP4.5-PRT42 PRECICE Plate 4.5mm Proximal Tibia Plate, Right, 45mm, 2-Hole; 00887517021281 LP4.5-PRT4B PRECICE Plate 4.5mm Proximal Tibia Plate, Right, 45mm, Bump; 00887517021274 LP4.5-SLF30 PRECICE Plate 4.5mm Shaft Plate, Left, 35mm, Long Magnet;
Where was it sold?
Worldwide distribution - U.S. Nationwide distribution and the countries of Argentina, Austria, Belgium, Canada, Chile, Colombia, Cyprus, Denmark, Finland, France, Germany, Greece, Hong Kong, Israel, Italy, Luxemburg, Netherlands, Portugal, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey and UAE. Consignee List provided only includes email addresses. Complete contact information is pending.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 87352| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Precice Bone Transport recalled by Nuvasive Specialized | Nuvasive Specialized Orthopedics | Other | Nationwide |
More recalls from Nuvasive Specialized Orthopedics
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Precice Max recalled by NuVasive Specialized | NuVasive Specialized Orthopedics | Other | FL, NV |
| Device | CLASS II | Nuvasive Magec 2 Rod recalled by NuVasive Specialized | NuVasive Specialized Orthopedics | Sterility | Nationwide |
| Device | CLASS II | Magec 1 System recalled by NuVasive Specialized | NuVasive Specialized Orthopedics | Other | CA |
| Device | CLASS II | Nuvasive Precice Intramedullary Limb Lengthening (Imll) recalled | Nuvasive Specialized Orthopedics | Packaging Defects | Nationwide |
| Device | CLASS II | Nuvasive Freedom: End Cap for Precice Intramedullary Limb recalled | Nuvasive Specialized Orthopedics | Packaging Defects | Nationwide |
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