Smith & Nephew, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2267-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156

Product Classification:

Class II

Date Initiated: May 11, 2018

Date Posted: June 27, 2018

Recall Number: Z-2267-2018

Event ID: 80126

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

Status: Terminated

Product Quantity: 2 units

Code Information:

(a) Size 58 mm, REF 74121158, Lot 16CW08945 (b) Size 56 mm, REF 74123156, Lot 16CW08246

Distribution Pattern:

OH, TX, CO, TN, MI, PA, NJ

Voluntary or Mandated:

Voluntary: Firm initiated