Recall Z-1045-2023 ยท KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008
| Date | Feb 1, 2023 (initiated Dec 22, 2022) |
| Status | Open, Classified |
| Reason | The recall is due to observed intra-operative screw failure. When pre-drilled with 1.3mm drill bit for 2.0mm screws and 1.6mm drill bit for 2.4mm we have observed screw failure due to excessive torque. |
| Root cause | Device Design |
| Action | Medline issued a MEDICAL DEVICE RECALL notice to its direct consignees on 01/05/2023 by US mail and its distributors on 01/07/2023 by email. The notice explained the problem and requested the following: "REQUIRED ACTION: 1. Immediately check your stock for the affected items. Quarantine all affected product. All consignment inventory will be addressed by your local Medline UNITE Sales Representative. 2. Please return the completed enclosed response form listing the quantity of affected product on hand. Even if you do not have any affected product please complete and return the form, as indi |
| Quantity | 420 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181280 | Patello-Femoral Wave (Kahuna) Arthroplasty System Arthrosurface, Inc., Jun 14, 2018 |