# FDA recall Z-2268-2018

> **Smith & Nephew, Inc.** · Class II · device recall initiated 2018-05-11.

## 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

## 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

## Key facts

- **Recall number:** Z-2268-2018
- **Recalling firm:** Smith & Nephew, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-11
- **Report date:** 2018-06-27
- **Termination date:** 2019-04-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Memphis, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2268-2018

## Citation

> AI Analytics. FDA recall Z-2268-2018. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-2268-2018. Source: US FDA. Licensed CC0.

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