FDA Device recall Z-1325-2021
PRECICE PLATE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, o…
- FDA Device
- Class II
- ongoing
- Published 2021-04-07
On 2021-04-07 the FDA classified a Class II recall of PRECICE PLATE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, o… by Nuvasive Specialized Orthopedics, citing 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 telescopin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1325-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-02-12 |
| Published | 2021-04-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Nuvasive Specialized Orthopedics |
| Distribution | US |
Product
PRECICE PLATE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
Reason
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.
Identifiers
| code_info | All Lots affected. Below are: Primary DI Number(GTIN)/Product Code (REF)/Product Description: 00887517021915 LP4.5…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-DR |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1325-2021%22
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