SteriSpine PS Kit (Safe Orthopaedics) – Incorrect Traceability Label (2022)
Incorrect patient label can cause potential confusion during medical device identification.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
Brand
SAFE ORTHOPAEDICS LLC
Lot Codes / Batch Numbers
KITM640: Lot numbers BF0A07 and 15BF001/R10, UDI 03760219910053, KITM645: Lot number BG0A02, UDI 03760219910060, and KITM740: Lot number BL0A01, UDI 03760219910091.
Products Sold
KITM640: Lot numbers BF0A07 and 15BF001/R10; UDI 03760219910053; KITM645: Lot number BG0A02; UDI 03760219910060; and KITM740: Lot number BL0A01; UDI 03760219910091.
SAFE ORTHOPAEDICS LLC is recalling SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, due to 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 correc. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MD
Page updated: Jan 10, 2026