DePuy S-ROM Noiles Rotating Hinge Femur Recall for Sterile Barrier Defects
DePuy Orthopaedics is recalling S-ROM Noiles Rotating Hinge Femur devices due to potential holes in the sterile barrier pouches.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a compromised sterile barrier, which poses a risk of infection (risk-of-harm product). No specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
DePuy Orthopaedics, Inc. has identified a potential defect in 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 for the devices. The outer carton and shrink wrap remain intact, but the compromised sterile barrier poses a risk to the sterility of the implant.
The recall affects 132 units of the S-ROM Noiles Rotating Hinge Femur with Pin, distributed worldwide to the United States, Canada, Australia, and numerous other international markets. These devices are used in revision knee surgeries when significant bone loss or ligament instability requires additional support. A package redesign is currently underway to resolve the issue.
During the pause in distribution, the devices will remain in US distributor inventory. Healthcare providers and patients should verify the lot numbers of their devices against the recall list and contact DePuy Orthopaedics for further instructions on replacement or return.
The recalled product
- Product
- REF 623421 RS-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right , X-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 n
- Manufacturer
- DePuy Orthopaedics, Inc.
- Affected units
- 132
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)
- Both Right and Left 102935
- 110571
- 114271
- 114274
- 114277
- 128477
- 132946
- 142857
- 156158
- 162498
- 162499
- 162500
- 172191
- 172194
- 193664
- 193668
- 217297
- 224704
- 229189
- 229192
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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