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Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup… recallZ-0862-2007 · Smith & Nephew Inc · initiated Mar 13, 2007

Terminated All recalls posted in June 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 reads BHR Acetabular Cup 60mm contained a 58mm cup.

FDA root cause category: Other

What the company is doing

The consignees (hospital CEOs) were notified of the problem and the recall by letter (Fed Ex) on 03/13/2007.

Recall details

Recall number
Z-0862-2007
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Mar 13, 2007
Posted by the FDA
Jun 7, 2007
Recalling firm
Smith & Nephew Inc
Quantity
1 unit
Product code
LXH
FDA submissions
P040033
Distribution
Europe. No domestic distribution.

Product description

Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 46 mm cup Ref.: 74120146

Code information (models, lots, serial numbers)

Lot Number: 64803

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 37782).

Sources and updates

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