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BIRMINGHAM HIP
Smith & Nephew, Inc. · Model 90123275 · UDI-DI 03596010606136
NXT
Prescription
0
510(k) clearances
6,885
Adverse events (18 deaths)
6
Recalls
9
Facilities
Description
3.2MM BIRMINGHAM HIP RE-DRILL HANDLE
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.