Birmingham Hip Resurfacing Acetabular Cup with Impactor: (a) Size 56 mm, REF 74120156 (b) Size 64 mm, REF 74120164 (c) S
FDA device recall Z-2268-2018 · posted 2018-05-21 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc.
- 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
- Action taken
- The firm initiated the recall by email and letter on 05/11/2018. Consignees are asked to inspect inventory, locate and quarantine affected, unused devices. Affected product will be returned to Smith & Nephew.
- Root cause
- Process control
- Status
- Terminated
- Product code
- NXT
- Quantity affected
- 6 units
- Distribution
- OH, TX, CO, TN, MI, PA, NJ
- Date initiated
- 2018-05-11
- Date posted
- 2018-05-21
- Date terminated
- 2019-04-05
- Location
- Memphis, TN
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