DePuy S-ROM Rotating Hinge Femoral Components Recalled for Sterile Barrier Defects
DePuy Orthopaedics is recalling S-ROM Noiles Rotating Hinge Femoral components due to potential holes in the sterile barrier pouches.
What this means for you
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, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The defect is a packaging integrity issue (sterile barrier) rather than a structural defect in the implant itself, and no injuries or illnesses have been reported.
Plain-English summary
DePuy Orthopaedics, Inc. has identified a potential defect in the sterile barrier packaging for S-ROM Noiles Rotating Hinge Femur with Pin devices. The issue involves the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier. The outer carton and shrink wrap remain intact, but the compromised inner barrier could affect the sterility of the device.
The affected product is the S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Small, Sterile. These devices are used in revision knee surgeries when there is significant bone loss or ligament instability. The recall covers 137 units distributed worldwide, including the United States, Canada, Australia, and various countries in Europe, Asia, and the Middle East.
A package redesign is currently underway to resolve the issue. The devices will remain in US distributor inventory during the pause in distribution. Healthcare providers and distributors should contact DePuy Orthopaedics for further instructions on handling the affected units.
The recalled product
- Product
- REF 623411 R S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Small, 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 nee
- Manufacturer
- DePuy Orthopaedics, Inc.
- Affected units
- 137
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)
- 102932
- 102933
- 102934
- 120086
- 142854
- 156155
- 156156
- 156157
- 162493
- 172189
- 181460
- 181462
- 193663
- 231692
- 231695
- 236448
- 241369
- 241371
- 246794
- 261763
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.
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