Recalls / —
—#164624
Product
Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156
- FDA product code
- NXT — Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
- Device class
- Class 3
- Medical specialty
- Unknown
- PMA numbers
- P040033
- Affected lot / code info
- (a) Size 58 mm, REF 74121158, Lot 16CW08945 (b) Size 56 mm, REF 74123156, Lot 16CW08246
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
Root cause (FDA determination)
Process control
Action the firm took
The firm initiated the recall by email and letter on 05/11/2018. Consignees are asked to inspect inventory, locate and quarantine affected, unused devices. Affected product will be returned to Smith & Nephew.
Recalling firm
- Firm
- Smith & Nephew, Inc.
- Address
- 1450 E Brooks Rd, Memphis, Tennessee 38116-1804
Distribution
- Distribution pattern
- OH, TX, CO, TN, MI, PA, NJ
Timeline
- Recall initiated
- 2018-05-11
- Posted by FDA
- 2018-05-21
- Terminated
- 2019-04-05
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #164624. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.