FDA Device recall Z-1323-2021
PRECICE STRYDE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions,…
- FDA Device
- Class II
- ongoing
- Published 2021-04-07
On 2021-04-07 the FDA classified a Class II recall of PRECICE STRYDE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions,… 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-1323-2021 |
| 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 STRYDE - 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: -887517981370 BT10-1…All Lots affected. Below are: Primary DI Number(GTIN)/Product Code (REF)/Product Description: -887517981370 BT10-100C360-5 Antegrade Tibia 10¿ Bend, 10.0mm x 360mm, 5/10cm ST; 887517981554 BT10-10A360-5 Retrograde Femur 10¿ Bend, 10.0mm x 360mm, 5/10cm ST; 887517981547 BT10-10A360-7 Retrograde Femur 10¿ Bend, 10.0mm x 360mm, 7/10cm ST; 887517981530 BT10-10A380-5 Retrograde Femur 10¿ Bend, 10.0mm x 380mm, 5/10cm ST; 887517981523 BT10-10A380-7 Retrograde Femur 10¿ Bend, 10.0mm x 380mm, 7/10cm ST; 887517981516 BT10-10A400-5 Retrograde Femur 10¿ Bend, 10.0mm x 400mm, 5/10cm ST; 887517981509 BT10-10A400-7 Retrograde Femur 10¿ Bend, 10.0mm x 400mm, 7/10cm ST; 887517981493 BT10-10B360-5 Antegrade Femur Piriformis Straight, 10.0mm x 360mm, 5/10cm ST; 887517981486 BT10-10B360-7 Antegrade Femur Piriformis Straight, 10.0mm x 360mm, 7/10cm ST; 887517981479 BT10-10B380-5 Antegrade Femur Piriformis Straight, 10.0mm x 380mm, 5/10cm ST; 887517981462 BT10-10B380-7 Antegrade Femur Pirifor |
|---|
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-1323-2021%22
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