SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws… recallZ-1572-2022 · Safe Orthopaedics LLC · initiated Jun 3, 2022
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Safe Orthopaedics LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Labeling Change Control
What the company is doing
The recall letter was issued on 6/3/2022 via email to the firm's one U.S. customer. The email included a dealer recall letter, dealer response form, and a template letter for notification of any hospitals who received the product from the dealer. The letter requested the products be quarantined and the dealer should contact the hospitals who received the product to notify them of the incorrect patient labels.
Recall details
- Recall number
- Z-1572-2022
- Status
- Completed
- Initiated by the company
- Jun 3, 2022
- Recalling firm
- Safe Orthopaedics LLC
- Quantity
- 8 devices
- Product code
- NKB
- FDA submissions
- K201648
- Distribution
- Distribution was made to MD. There was no government/military distribution.
Product description
SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
Code information (models, lots, serial numbers)
KITM640: Lot numbers BF0A07 and 15BF001/R10; UDI 03760219910053; KITM645: Lot number BG0A02; UDI 03760219910060; and KITM740: Lot number BL0A01; UDI 03760219910091.
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- STERISPINE PS KITM640Safe Orthopaedics · Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease1 recall0 reports
- STERISPINE PS KITM645Safe Orthopaedics · Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease1 recall0 reports
- STERISPINE PS KITM740Safe Orthopaedics · Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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