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Zimmer Trabecular metal primary hip prosthesis femoral… recallZ-1471-06 · Zimmer Inc. · initiated Aug 2, 2006

Terminated All recalls posted in August 2006

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 Zimmer 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

Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly.

FDA root cause category: Other

What the company is doing

Consignees were notified via letter dated 8/2/06 to cease use of and to return the products. Zimmer distributors were to examine stock and return product on hand.

Recall details

Recall number
Z-1471-06
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Aug 2, 2006
Posted by the FDA
Aug 31, 2006
Recalling firm
Zimmer Inc.
Quantity
181 of all devices
Product code
LPH
FDA submissions
K051491
Distribution
Worldwide, including USA, Australia, China, Denmark, Japan, Jordan, Latin Ameria, Russia, Singapore and Switzerland.

Product description

Zimmer Trabecular metal primary hip prosthesis femoral stem, press-fit, collarless, 12/14 neck taper - standard body -extended neck offset, size 14, 149 mm stem length, sterile, tivanium TI-6AL-4V alloy/tantalum, sterile; Cat. no. 00-7864-014-20 (00786401420).

Code information (models, lots, serial numbers)

Lots 60465254 and 60469823.

Other devices under the same FDA submission

9 devices cleared under K051491 — 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 35943).

Sources and updates

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