Recall Z-2268-2018
Smith & Nephew, Inc. · initiated May 11, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Birmingham Hip Resurfacing Acetabular Cup with Impactor: (a) Size 56 mm, REF 74120156 (b) Size 64 mm, REF 74120164 (c) Size 54 mm, REF 74122154 (d) Size 58 mm, REF 74122158 (e) Size 60 mm, REF 74122160 (f) Size 62 mm, REF 74122162
Codes / lots: (a) Size 56 mm, REF 74120156, Lot 16CW01824 (b) Size 64 mm, REF 74120164, Lot 16DW10975 (c) Size 54 mm, REF 74122154, Lot 16BW17747 (d) Size 58 mm, REF 74122158, Lot 16CW16199 (e) Size 60 mm, REF 74122160, Lot 08GW18001B (f) Size 62 mm, REF 74122162, Lot 16CW20851
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
FDA-determined 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.
Details
- Recall number
- Z-2268-2018
- Initiated
- May 11, 2018
- Posted by FDA
- May 21, 2018
- Terminated
- April 5, 2019
- Product code
- NXT – Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
- Quantity
- 6 units
- Distribution
- OH, TX, CO, TN, MI, PA, NJ
- Recalling firm
- Smith & Nephew, Inc., Memphis, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2267-2018 Class II | Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm…The affected devices are manufactured to the same design specification as products intended for sale and use… | 05/11/2018Terminated |