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Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup… recallZ-0032-2008 · Smith & Nephew Inc · initiated Jul 12, 2007

Terminated All recalls posted in October 2007

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 carton label may not reflect the correct size of the acetabular cup.

FDA root cause category: Packaging process control

What the company is doing

The consignees were notified of the problem and the recall by initially by telephone on 07/12/2007 and followed by a letter dated 07/24/2007.

Recall details

Recall number
Z-0032-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jul 12, 2007
Posted by the FDA
Oct 25, 2007
Recalling firm
Smith & Nephew Inc
Quantity
1 unit
Product code
LXH
FDA submissions
P040033
Distribution
Worldwide, including USA, Australia, Belgium, Canada, Finland, France, Germany, Italy, The Netherlands, Norway, South Africa, Spain, Switzerland, and United Kingdom.

Product description

Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120258. Hip implant component.

Code information (models, lots, serial numbers)

Lot Number 66949

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 39402).

Sources and updates

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