The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2414-2012·Announced 2012-09-26

DePuy S-ROM Total Hip System Poly Liner Recalled for Labeling Error

DePuy Orthopaedics is voluntarily recalling four lots of S-ROM Total Hip System Poly Liners because the carton labels contain an incorrect color code series designation.

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 2/5 (Moderate).

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 and involves a minor labeling error (incorrect color code) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

DePuy Orthopaedics, Inc. is issuing a voluntary recall of four lots of the S-ROM Total Hip System Poly Liner. The recall is due to an incorrect color code series designation on the carton labels. The company has received one complaint regarding this specific labeling issue.

The affected product is the S-ROM Total Hip System Poly Liner, which is part of the S-ROM Total Hip System. The liner is fitted inside the acetabular shell and serves as the bearing surface for the head on the S-ROM stem. It is intended for total hip arthroplasty to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation.

The recall involves 12 liners distributed nationwide, including in Massachusetts, Texas, Ohio, California, and North Carolina. The affected catalogue lot numbers are 87-5987, 3189424, 3312166, and 3402685. The agency has classified this as a Class II recall.

The recalled product

Product
S-Rom¿ Total Hip System Poly Liner Packaging: The insert is placed into an inner foil pouch and vacuum sealed; a ring is placed into a Tyvek/PET pouch and sealed; the foil pouch and Tyvek/PET pouch are placed into a nylon outer pouch and sealed. This is then placed into a…
Manufacturer
DePuy Orthopaedics, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
12

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 (1)

  • Catalogue Lot Number 87-5987 3189424 3312166 3340992 3402685

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

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