Reported Jun 27, 2018 · Terminated
Birmingham Hip Resurfacing Acetabular Cup with Impactor
Smith & Nephew, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smith & Nephew, Inc. · 1450 E Brooks Rd · Memphis, TN · 38116-1804
Is this the product you have?
12 of 12 products
| Model / number | Product as published |
|---|---|
74120156 | — |
| — | Lot 16CW01824 (b) Size 64 mm |
74120164 | — |
| — | Lot 16DW10975 (c) Size 54 mm |
74122154 | — |
| — | Lot 16BW17747 (d) Size 58 mm |
74122158 | — |
| — | Lot 16CW16199 (e) Size 60 mm |
74122160 | — |
| — | Lot 08GW18001B (f) Size 62 mm |
74122162 | — |
| — | Lot 16CW20851 |
- Amount recalled
- 6 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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 Patient Information Brochure). The affected devices were distributed in the US with the IFU intended for use outside of the US
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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