DePuy S-ROM Noiles Rotating Hinge Femur Recall for Sterile Barrier Defect
DePuy Orthopaedics is recalling S-ROM Noiles Rotating Hinge Femur devices because holes may develop in the sterile barrier pouches, potentially compromising sterility.
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 is classified as FDA Class II, and the hazard involves a potential breach of the sterile barrier for an implantable medical device, which poses a risk of infection or harm, but no specific injuries or illnesses are reported in the source text.
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 form the sterile barrier for these devices. While the outer carton and shrink wrap remain intact, the compromised pouches could affect the sterility of the implant.
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 130 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 this issue. During the recall period, the affected devices will remain in US distributor inventory. Healthcare providers and distributors should check their inventory for the specific lot codes listed in the recall notice and stop using the affected units until further notice.
The recalled product
- Product
- REF 623421 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left , 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
- 130
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 left and Right 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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