Z-2548-2014Class II

Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD 53MM DIA, ENDO FEMORAL HEAD 47MM...

Name: Z-2548-2014 Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD 53MM DIA, ENDO FEMORAL HEAD 47MM...
Creator: Zimmer, Inc.
Published: 2014-07-22
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2014-07-22 / Terminated / root cause: packaging

FDA source

Zimmer, Inc. began a recall of 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... on 2014-07-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2548-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-22
Posted: 2014-08-26
Terminated: 2015-09-15
Recalling firm: Zimmer GmbH
Product: 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
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: 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.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: 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.
Quantity in commerce: 972,125 units
Distribution: Worldwide Distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2548-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2546-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-26
Z-2547-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-26
Z-2548-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-26
Z-2549-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-26
Z-2550-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-26
Z-2551-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-26
Z-2552-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-26

Product code JDI

K960278Class IICobalt-Chromium-Molybdenum (Co-Cr-Mo) Alloy Femoral Heads W/co-Nidium Surface TreatmentZimmer, Inc. / cleared 1996-07-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)