Recall Z-2445-2024 ยท HWT Template
LINK BIO CORP
LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00
| Date | Jul 25, 2024 (initiated Jun 27, 2024) |
| Status | Open, Classified |
| Reason | The LinkSymphoKnee Patella Sizing Template was incorrectly labeled. The markings on two arms of the instrument were mixed up because the triangular Patella Sizing Template was inserted upside down into the laser marking process. |
| Root cause | Process change control |
| Action | On June 27, 2024 URGENT: MEDICAL DEVICE RECALL letters were sent via email to distributors. Actions to be taken by the Customer/User: Please check your inventory for this item and lot combination. If the markings are incorrect, as indicated in Section 5 below, please return the affected product to LinkBio. Please respond using the attached Distributor Reply form to indicate your understanding of this Device Recall and of the need to return any affected product. Pre-paid shipping labels will be provided once the Distributor Reply Form is returned, should any affected product be identified. Plea |
| Quantity | 8 units |
| Distribution | US Nationwide distribution in the states of FL, GA, KS, OH, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.