Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2548-2014·Announced 2014-09-03

Zimmer Recalls Endo and Unipolar Femoral Heads Due to Packaging Failures

Zimmer, Inc. is recalling 972,125 units of Endo and Unipolar Femoral Heads because packaging design verification tests failed, potentially compromising sterility.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a packaging integrity failure that could compromise sterility, but the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Zimmer, Inc. is recalling sterile-packaged Endo and Unipolar Femoral Heads in various diameters (41mm to 55mm). The recall involves 972,125 units that were distributed worldwide. The devices are identified by specific item numbers and lot numbers listed in the recall documentation.

The recall was initiated due to packaging design verification test failures. Multiple test samples from six different package configurations failed simulated distribution and shipping testing. During these tests, the devices either breached the inner or outer package trays or lost seal integrity. This failure mode suggests that the sterile barrier may be compromised during shipping or distribution.

Healthcare providers and patients who have received these implants should contact Zimmer, Inc. for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.

The recalled product

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…
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implants
Hazard: packaging-integrity
sterility-compromise
Affected units: 972,125

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Item Numbers : 00781804300
00781805300
00781804700
00781805000
00781804200
00781805400
00781804800
00781804100
00781804300
00781804400
00781804500
00781804600
00781804900
00781805100
00781805200
00781805500 Lot Numbers: 37210958
37210967
37211180
37211183
37211311

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 7 recalled by Zimmer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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