FDA Medical Device Recalls (openFDA)
Stanmore Implants Worldwide Ltd.: METS SMILES Total Knee Replacement
- Recall number
- Z-2553-2016
- Recalling firm
- Stanmore Implants Worldwide Ltd.
- Product
- METS SMILES Total Knee Replacement
- Status
- Terminated
- Initiated
- 2016-05-31
- Posted
- 2016-08-17
- Terminated
- 2017-03-02
- Reason
- 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.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 3 units
- Distribution
- Directly distributed to TX, further distributed to AL and MS
- Lot, serial or model codes
- Catalogue Numbers: mkfp/Std5 and mkfp/Std10 Batch Numbers: B4311 and B5470
- 510(k) numbers
- ["K120992"]
- PMA numbers
- not on file
- Product code
- KRO
- Firm FEI
- 3004105610
- Firm city
- Borehamwood
- Firm state
- Centennial
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28