The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1315-2021·Announced 2021-04-07

DePuy Orthopaedics Recalls Mobile Bearing Total Knee Systems Due to Packaging Damage

DePuy Orthopaedics is recalling specific lots of the LCS COMPLETE P.F.C. SIGMA RP Mobile Bearing Total Knee System because of potential damaged packaging.

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, but the hazard is limited to potential damaged packaging without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

DePuy Orthopaedics, Inc. is recalling 102 units of the LCS COMPLETE P.F.C. SIGMA RP Mobile Bearing Total Knee System. The recall involves specific tibial base components used in total knee arthroplasty, which are designed for cemented applications. The company is removing these lots due to potential damaged packaging.

The affected products were distributed worldwide, including nationwide in the United States and in numerous international countries. The recall covers eight specific lot numbers associated with product codes 129433130 and 129433140.

Healthcare providers and patients should check their inventory or medical records for the specific lot numbers listed in the recall notice. If a patient has received an implant from one of the affected lots, they should contact their healthcare provider for further guidance.

The recalled product

Product
The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.
Manufacturer
DePuy Orthopaedics, Inc.
Category
Medical Device — Orthopedic Implants
Hazard

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 (11)

  • Lot#: 9543538
  • Product Code: 129433130
  • GTIN 10603295025788 Lot#: 9553989
  • GTIN 10603295025788 Lot#: 9554547
  • GTIN 10603295025788 Lot#: 9554548
  • GTIN 10603295025788 Lot#: 9554551
  • GTIN 10603295025788 Lot#: 9548774
  • Product Code: 129433140
  • GTIN 10603295025795 Lot#: 9548777
  • GTIN 10603295025795 Lot#: 9554569
  • GTIN 10603295025795

Distribution

Distributed nationwide across the United States.

The notice also names 39 states specifically:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

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