Recall Z-1572-2022 · NKB Thoracolumbosacral Pedicle Screw System
SAFE ORTHOPAEDICS LLC
SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
| Date | Jun 3, 2022 |
| Status | Completed |
| Reason | 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. |
| Root cause | Labeling Change Control |
| Action | 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. |
| Quantity | 8 devices |
| Distribution | Distribution was made to MD. There was no government/military distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201648 | Sterispine PS Safe Orthopaedics, Jul 30, 2020 |