Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156
This recall has been terminated (originally issued May 21, 2018).
- Company
- Smith & Nephew Inc
- Recall Initiated
- May 11, 2018
- Posted
- May 21, 2018
- Terminated
- April 5, 2019
- Recall Number
- Z-2267-2018
- Quantity
- 2 units
- Firm Location
- Memphis, TN
- Official Source
- View on FDA website ↗
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
Distribution
OH, TX, CO, TN, MI, PA, NJ
Lot / Code Info
(a) Size 58 mm, REF 74121158, Lot 16CW08945 (b) Size 56 mm, REF 74123156, Lot 16CW08246
Root Cause
Process control
Action Taken
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.
More recalls by Smith & Nephew Inc
Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 713...
Nov 7, 2024
smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW...
Oct 31, 2024