Smith & Nephew, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2268-2018)

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 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

Product Classification:

Class II

Date Initiated: May 11, 2018

Date Posted: June 27, 2018

Recall Number: Z-2268-2018

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: 6 units

Code Information:

(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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated