Chicago, IL, United States
SAFE ORTHOPAEDICS LLC recalls
1 recall recorded since 2018, most recently on 3 June 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Completed Class II Medical devices
- Recall started
- 3 June 2022
- Reason
- The type of screw printed on the traceability record for the patient label is incorrect, but the type of screw printed on the other labeling is correct.
- Distribution
- Distribution was made to MD. There was no government/military distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1572-2022
- SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.