CLASS II Device recall · Reported 31 Aug 2022 · FDA Enforcement Report
SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws recalled
Safe Orthopaedics is recalling SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, distributed in Maryland. The recall was initiated on 3 Jun 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1572-2022
- FDA event ID
- 90542
- Recalling firm
- Safe Orthopaedics, Chicago, IL
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 3 Jun 2022
- FDA classified
- 24 Aug 2022
- Reported
- 31 Aug 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 3 Jun 2022 | Recall initiated by company | |
| 24 Aug 2022 | Classified by FDA | +82 days |
| 31 Aug 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
Where it was distributed
Distribution was made to MD. There was no government/military distribution.
Questions about this recall
Why was it 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.
Which lots are affected?
KITM640: Lot numbers BF0A07 and 15BF001/R10; UDI 03760219910053; KITM645: Lot number BG0A02; UDI 03760219910060; and KITM740: Lot number BL0A01; UDI 03760219910091.
Where was it sold?
Distribution was made to MD. There was no government/military distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |