SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws recall: Labeling Error
SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
Why was SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
KITM640: Lot numbers BF0A07 and 15BF001/R10; UDI 03760219910053; KITM645: Lot number BG0A02; UDI 03760219910060; and KITM740: Lot number BL0A01; UDI 03760219910091.
- Product
- SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
- Recalling firm
- SAFE ORTHOPAEDICS LLC
- Quantity
- 8 devices
- Distribution
- Distribution was made to MD. There was no government/military distribution.
- Recall date
- August 31, 2022
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)