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smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14… recallZ-1921-2018 · Smith & Nephew, Inc. · initiated May 2, 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

Three lots of Anthology HO Porous size 7 stems were manufactured with an undersized taper length. The device taper length was incorrectly manufactured as 0.393mm opposed to 0.442 mm.

FDA root cause category: Process control

What the company is doing

The firm initiated the recall by letter on 05/02/2018. Consignees are asked to inspect inventory, locate and quarantine affected, unused devices. Affected product will be returned to Smith & Nephew. All consignees are asked to complete the Response Form, even if they do not have product to return. Distributors were directed to notify their customers of the field action and ensure that these actions are carried out. For further questions, please call (978) 749-1440

Recall details

Recall number
Z-1921-2018
Recall class
Class II
Status
Terminated
Initiated by the company
May 2, 2018
Posted by the FDA
May 9, 2018
Recalling firm
Smith & Nephew, Inc.
Quantity
13 units
Product code
JDI
FDA submissions
K052792
Distribution
US nationwide distribution.

Product description

smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip prosthesis.

Code information (models, lots, serial numbers)

Lot Numbers: 17LM22019, 17LM10934, 17LM05900

Other devices under the same FDA submission

1 device cleared under K052792 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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