Z-2268-2018 Class II Terminated
FDA device recall Z-2268-2018 was initiated by Smith & Nephew, Inc. on May 11, 2018 and is designated Class II. 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… The recall status is terminated (terminated Apr 5, 2019). Affected quantity: 6 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 27, 2018
- Initiation Date
- May 11, 2018
- Termination Date
- Apr 5, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
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
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 Pattern
OH, TX, CO, TN, MI, PA, NJ
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2268-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026