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MATRIX
Smith & Nephew, Inc. · Model MT2201 · UDI-DI 03596010012302
NXT
Prescription
0
510(k) clearances
6,886
Adverse events (18 deaths)
6
Recalls
9
Facilities
Description
MATRIX CEMENTED CUP X BAR
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-07-14 | Smith & Nephew Orthopaedics Ltd. (Aurora) | The nail head may become detached during surgery. |
| 2018-05-11 | Smith & Nephew, Inc. | The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and P |
| 2018-05-11 | Smith & Nephew, Inc. | The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and P |
| 2015-06-03 | Smith & Nephew, Inc. | The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks. |
| 2015-06-03 | Smith & Nephew, Inc. | The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks. |
| 2015-06-03 | Smith & Nephew, Inc. | The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.