Agency classClass IIOur severity:High FDA (Devices)·Z-1205-2014·Announced 2014-03-19

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.

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 implanted medical device, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

DePuy Orthopaedics, Inc. is recalling 134 units of the S-ROM Noiles Rotating Hinge Femur with Pin devices. The recall was initiated because the company identified a potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for these devices. The outer carton and shrink wrap remain intact, but the defect in the flexible pouches poses a risk to the sterility of the implant.

These devices are used in revision knee surgeries when there is significant bone loss or ligament instability. The affected units were distributed worldwide, including nationwide in the United States and internationally to numerous countries such as Canada, Australia, and the United Kingdom. A package redesign is currently underway to resolve the issue.

The 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 units. Patients who have already received these implants should contact their healthcare provider for guidance.

The recalled product

Product: REF 623411 L, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, 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…
Manufacturer: DePuy Orthopaedics, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: sterility-compromise
infection-risk
Affected units: 134

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)

E1VHS4
430482
338164
373256
395802
409578
448220
409582
238688
430483
306508
329330
264451
448222
216275
373255
346439
409580
338165
250929

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 · sterility compromise