Birmingham Hip Resurfacing Acetabular Cup with Impactor: — Class II medical device recall Z-2268-2018
Terminated recall by Smith & Nephew, Inc., reported 2018-06-27, distributed in CO, MI, NJ, OH, PA, TN, TX. The affected devices are manufactured to the same design specification as products intended for sale and use i
| Recall number | Z-2268-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2018-05-11 |
| Classified | 2018-06-21 |
| Reported by FDA | 2018-06-27 |
| Terminated | 2019-04-05 |
| Distributed | CO, MI, NJ, OH, PA, TN, TX |
| Quantity | 6 units |
| Reason classes | labeling |
| Lot numbers | 08GW18001B, 16BW17747, 16CW01824, 16CW16199, 16CW20851, 16DW10975 |
| Model numbers | 74120156, 74120164, 74122154, 74122158, 74122160, 74122162 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2268-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.