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Stryker Howmedica Osteonics, Skirted 5 40' Taper V40… recallZ-0390-2010 · Stryker Howmedica Osteonics Corp. · initiated Sep 4, 2009

Terminated All recalls posted in November 2009

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 Stryker Howmedica Osteonics Corp. 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

Packaging mix up between the Taper V40 Femoral Head and the LFIT V40 Femoral Head.

FDA root cause category: Process control

What the company is doing

Stryker sent Notification letters and Product Accountability Forms via FedEx on September 4, 2009 with return receipt. Corrected letters were sent on September 9, 2009.

Recall details

Recall number
Z-0390-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Sep 4, 2009
Posted by the FDA
Nov 23, 2009
Recalling firm
Stryker Howmedica Osteonics Corp.
Quantity
7 units
Product code
JDG
FDA submissions
K010757, K022077, K061434, K993601
Distribution
Nationwide distribution.

Product description

Stryker Howmedica Osteonics, Skirted 5 40' Taper V40 Femoral Head (26 mm +8mm offset), hip prosthesis component.

Code information (models, lots, serial numbers)

Catalog number 6260-5-326; Lot code 29018201

Other devices under the same FDA submission

22 devices cleared under K010757, K022077, K061434, K993601 — 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 53434).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page