Recall Z-1572-2022
Safe Orthopaedics LLC · initiated June 3, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
Codes / lots: KITM640: Lot numbers BF0A07 and 15BF001/R10; UDI 03760219910053; KITM645: Lot number BG0A02; UDI 03760219910060; and KITM740: Lot number BL0A01; UDI 03760219910091.
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.
FDA-determined cause: Labeling Change Control
Action taken
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.
Details
- Recall number
- Z-1572-2022
- Initiated
- June 3, 2022
- Product code
- NKB – Thoracolumbosacral Pedicle Screw System
- Quantity
- 8 devices
- Distribution
- Distribution was made to MD. There was no government/military distribution.
- Recalling firm
- Safe Orthopaedics LLC, Chicago, IL