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Birmingham Hip Resurfacing Femoral Head recallZ-2267-2018 · Smith & Nephew, Inc. · initiated May 11, 2018

Class II Terminated All recalls posted in May 2018

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Smith & Nephew, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-2267-2018
Recall class
Class II
Status
Terminated
Initiated by the company
May 11, 2018
Posted by the FDA
May 21, 2018
Recalling firm
Smith & Nephew, Inc.
Quantity
2 units
Product code
NXT
FDA submissions
P040033
Distribution
OH, TX, CO, TN, MI, PA, NJ

Product description

Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156

Code information (models, lots, serial numbers)

(a) Size 58 mm, REF 74121158, Lot 16CW08945 (b) Size 56 mm, REF 74123156, Lot 16CW08246

Other devices under the same FDA submission

57 devices cleared under P040033 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 80126).

Sources and updates

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