Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156
Reported: June 27, 2018 Initiated: May 11, 2018 #Z-2267-2018
Product Description
Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156
Reason for Recall
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
Details
- Recalling Firm
- Smith & Nephew, Inc.
- Units Affected
- 2 units
- Distribution
- OH, TX, CO, TN, MI, PA, NJ
- Location
- Memphis, TN
Frequently Asked Questions
What product was recalled? ▼
Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156. Recalled by Smith & Nephew, Inc.. Units affected: 2 units.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 27, 2018. Severity: Moderate. Recall number: Z-2267-2018.
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