Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2552-2014·Announced 2014-09-03

Zimmer Recalls Knee Stem Extensions Due to Packaging Design Failures

Zimmer, Inc. is recalling specific knee stem extensions and impactor sleeves because packaging design verification tests failed, potentially compromising device 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 poses a theoretical risk to sterility, but the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Zimmer, Inc. is recalling sterile-packaged knee stem extensions and impactor sleeves. The recall involves 972,125 units distributed worldwide. The affected products include various stem implants, sharp fluted stems, cemented stem extensions, and impactor sleeves, identified by specific item numbers and expiration dates prior to July 2024.

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, devices either breached the inner or outer package trays, or the seal integrity was lost. This failure mode suggests a potential risk to the sterility of the implants.

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

The recalled product

Product: Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLANT 22MMDX145MM STEM IMPLANT 24MMDX145MM SHARP FLUTED ST 20MMDX75MM SHARP FLUTED ST 22MMDX75MM SHARP FLTD ST 24MMDX75MM SHARP FLUTED ST 20MMDX130MM SHARP FLUTED ST 22MMDX130MM SHARP FLUTED ST…
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implants
Hazard: packaging-integrity
sterility-risk
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:00598801020
00598801022
00598801024
00598801520
00598801522
00598801524
00598801620
00598801622
00598801624
00598801913
31810604200
32598801212
32598801213
32598801214
32598801215
32598801216
32598801217
32598801218
32598801220
32598801222

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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