METS SMILES Total Knee Replacement
FDA device recall Z-2553-2016 · posted 2016-08-17 · Terminated
Recall details
- Recalling firm
- Stanmore Implants Worldwide Ltd.
- Reason for recall
- The manufacturer has identified that the stated Femoral Plateau Plates may not fit into the intended Femoral Knee mating component and thus sit flush upon the Femoral Knee component prior to implantation.
- Action taken
- The recalling firm sent recall notification letters to their consignees on 05/31/2016. Follow up communciation was sent out on 7/26/2016 after a technical and medical assessment was completed.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KRO
- Quantity affected
- 3 units
- Distribution
- Directly distributed to TX, further distributed to AL and MS
- Date initiated
- 2016-05-31
- Date posted
- 2016-08-17
- Date terminated
- 2017-03-02
- Location
- Borehamwood, Centennial, United Kingdom
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| METS SMILES TOTAL KNEE REPLACEMENT (K120992) | Stanmore Implants Worldwide , Ltd. | 2012-09-05 |