The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1204-2014·Announced 2014-03-19

DePuy S-ROM Noiles Rotating Hinge Femur Recalled for Sterile Barrier Defects

DePuy Orthopaedics is recalling S-ROM Noiles Rotating Hinge Femur devices because holes may develop in the sterile barrier pouches, potentially compromising 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 3/5 (High).

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 potential breach of the sterile barrier for an implantable medical device, which is a high-risk hazard. No illnesses or injuries have been reported, and the agency classification is Class II, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

DePuy Orthopaedics, Inc. is recalling S-ROM Noiles Rotating Hinge Femur with Pin devices due to 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 sterile barrier poses a risk to the device's sterility. A package redesign is currently underway to resolve this issue.

The recalled devices are used in revision knee surgeries when significant bone loss or ligament instability requires additional support. The recall affects 128 units distributed worldwide, including the United States, Canada, Australia, and various countries in Europe, Asia, and the Middle East. Specific lot codes are listed in the recall documentation.

DePuy Orthopaedics states that the affected devices will remain in US distributor inventory during the recall process. Healthcare providers and distributors should check their inventory for the specific lot codes listed in the recall notice and stop using any affected devices. Patients who have already received these implants should contact their healthcare provider for guidance.

The recalled product

Product
REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, 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
Affected units
128

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)

  • 102325
  • 102326
  • 109315
  • 109316
  • 120082
  • 128475
  • 142843
  • 142845
  • 162487
  • 197812
  • 197813
  • 197814
  • 207924
  • 222654
  • 222657
  • 231689
  • 231690
  • 236435
  • 236442
  • 261758

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 →

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