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Endo & Unipolar Femoral Heads recallZ-2548-2014 · Zimmer, Inc. · initiated Jul 22, 2014

Class II Terminated All recalls posted in August 2014

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

Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.

FDA root cause category: Package design/selection

What the company is doing

Zimmer sent an URGENT MEDICAL DEVICE RECALL letter dated July 2014 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Please call the Customer Call Center at 1-800-348-2759 for questions or concerns involving this notice.

Recall details

Recall number
Z-2548-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Jul 22, 2014
Posted by the FDA
Aug 26, 2014
Recalling firm
Zimmer, Inc.
Quantity
972,125 units
Product code
JDI
FDA submissions
K960278
Distribution
Worldwide Distribution.

Product description

Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD 53MM DIA, ENDO FEMORAL HEAD 47MM DIA, ENDO FEMORAL HEAD 50MM DIA, ENDO FEMORAL HEAD 42MM DIA, ENDO FEMORAL HEAD 54MM DIA, ENDO FEMORAL HEAD 48MM DIA, ENDO FEMORAL HEAD 41MM DIA, ENDO FEMORAL HEAD 42MM DIA, ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD 44MM DIA, ENDO FEMORAL HEAD 45MM DIA, ENDO FEMORAL HEAD 46MM DIA, ENDO FEMORAL HEAD 47MM DIA, ENDO FEMORAL HEAD 48MM DIA, ENDO FEMORAL HEAD 49MM DIA, ENDO FEMORAL HEAD 50MM DIA, ENDO FEMORAL HEAD 51MM DIA, ENDO FEMORAL HEAD 52MM DIA, ENDO FEMORAL HEAD 53MM DIA, ENDO FEMORAL HEAD 54MM DIA, ENDO FEMORAL HEAD 55MM DIA

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

Item Numbers : 00781804300, 00781805300, 00781804700, 00781805000, 00781804200, 00781805400, 00781804800, 00781804100, 00781804200, 00781804300, 00781804400, 00781804500, 00781804600, 00781804700, 00781804800, 00781804900, 00781805000, 00781805100, 00781805200, 00781805300, 00781805400, 00781805500   Lot Numbers: 37210958, 37210967, 37211180, 37211183, 37211311, 37211316, 37211320, 37211379, 37211482, 62561484, 37211643, 37211645, 37211646, 37211647, 37211653, 37211655, 37211657, 37211658, 37211661, 37211801, 37211804, 37211805, 37211806, 37211811, 37211812, 37211815, 37211817, 37211820, 37212062, 37212063, 37212065, 37212074, 37212079, 62573574, 62573576, 62576002, 62576008, 62593298, 62593302, 37212608, 37211644

Other devices under the same FDA submission

1 device cleared under K960278 — 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 68818).

Sources and updates

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