SteriSpine PS surgical screws recalled for patient label mislabeling
FDA recalls 8 SteriSpine PS multi-axial fenestrated screw kits distributed in Maryland due to incorrect labeling on patient documentation. The patient labels list the wrong screw type, though other labeling and the devices themselves are correct.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is a labeling discrepancy on patient documentation rather than a product defect, fitting the rubric criterion for minor labeling errors.
Plain-English summary
SAFE ORTHOPAEDICS LLC is recalling 8 SteriSpine PS kits containing multi-axial fenestrated screws (models KITM640, KITM645, and KITM740) distributed to a healthcare provider in Maryland. The patient label for the traceability record lists an incorrect screw type, though the devices themselves and other product labeling correctly identify the actual screw type.
This labeling discrepancy could affect medical records and patient follow-up care. The recall is classified as FDA Class II and involves devices with specific lot numbers and unique device identifiers.
Affected lot numbers include BF0A07 and 15BF001/R10 for model KITM640, BG0A02 for model KITM645, and BL0A01 for model KITM740. Distribution was limited to Maryland, with no government or military distribution.
The recalled product
- Product
- SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
- Manufacturer
- SAFE ORTHOPAEDICS LLC
- Hazard
- mislabeling
- traceability-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- KITM640: Lot numbers BF0A07 and 15BF001/R10
- UDI 03760219910053
- KITM645: Lot number BG0A02
- UDI 03760219910060
- and KITM740: Lot number BL0A01
- UDI 03760219910091.
Distribution
Distributed in 1 state:
- MD
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