FDA Device recall Z-1572-2022
SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740
- FDA Device
- Class II
- completed
- Published 2022-08-31
On 2022-08-31 the FDA classified a Class II recall of SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740 by Safe Orthopaedics, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1572-2022 |
| Classification | Class II |
| Status | completed |
| Initiated | 2022-06-03 |
| Published | 2022-08-31 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Safe Orthopaedics |
| Distribution | MD |
Product
SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
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.
Identifiers
| code_info | KITM640: Lot numbers BF0A07 and 15BF001/R10; UDI 03760219910053; KITM645: Lot number BG0A02; UDI 03760219910060; and…KITM640: Lot numbers BF0A07 and 15BF001/R10; UDI 03760219910053; KITM645: Lot number BG0A02; UDI 03760219910060; and KITM740: Lot number BL0A01; UDI 03760219910091. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1572-2022%22
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