Recall Z-0820-2017 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Stanmore Implants Worldwide Ltd.
Tibial Component Fixed Hinge Small Long; Tibial Component Fixed Hinge Small Short The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
| Date | Dec 19, 2016 (initiated Dec 7, 2016) |
| Status | Terminated |
| Reason | The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem. |
| Root cause | Packaging |
| Action | Stanmore Implants sent an Urgent Field Safety Notice dated November 25, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to immediately check their internal inventory and quarantine all subject devices, circulate the Field Safety Notice internally to all interested/affected parties, maintain awareness of the notice internally until all required actions have been completed within their facility, inform Stanmore Implants if any of the subject devices have been distributed to other organizations |
| Quantity | 13 units |
| Distribution | Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120992 | METS SMILES TOTAL KNEE REPLACEMENT Stanmore Implants Worldwide , Ltd., Sep 5, 2012 |