Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1203-2014·Announced 2014-03-19

DePuy S-ROM Rotating Hinge Recall Due to Sterile Barrier Defect

DePuy Orthopaedics is recalling S-ROM Noiles Rotating Hinge Femur devices because holes may develop in the sterile barrier pouches.

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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a potential sterile barrier failure, which fits the criteria for a moderate severity recall involving low-risk contamination or precautionary measures without reported harm.

Plain-English summary

DePuy Orthopaedics, Inc. is recalling S-ROM Noiles Rotating Hinge Femur with Pin devices due to a potential defect in the sterile barrier system. The company identified that holes may develop in the inner and outer flexible pouches that protect the device, although the outer carton and shrink wrap remain intact.

The S-ROM Noiles Rotating Hinge Femur with Pin is a medical device used in revision knee surgeries when significant bone loss or ligament instability requires additional support. The recall involves 129 units that were distributed nationwide in the United States and internationally to numerous countries including Canada, Australia, and various nations in Europe, Asia, and the Middle East.

A package redesign is currently underway to resolve the issue. The recalled devices will remain in the inventory of US distributors during the recall process.

The recalled product

Product: REF 623401 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, medium, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is…
Manufacturer: DePuy Orthopaedics, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: sterile-barrier-failure
contamination
Affected units: 129

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)

249649
102928
102929
109312
128472
142839
142840
142841
162485
196050
196051
196052
211382
211387
213581
227387
231687
249644
249647
269701

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by DePuy Orthopaedics, 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 6 products in this recall →

Same manufacturer · DePuy Orthopaedics, Inc.

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Same hazard · sterile barrier failure