Birmingham Hip Resurfacing Femoral Head recall: Labeling Error
Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156
Why was Birmingham Hip Resurfacing Femoral Head 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
(a) Size 58 mm, REF 74121158, Lot 16CW08945 (b) Size 56 mm, REF 74123156, Lot 16CW08246
- Product
- Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156
- Recalling firm
- Smith & Nephew, Inc.
- Quantity
- 2 units
- Distribution
- OH, TX, CO, TN, MI, PA, NJ
- Recall date
- June 27, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)