Agency classClass IIOur severity:High FDA (Devices)·Z-0913-2024·Announced 2024-02-07

Knee Replacement Device Recalled Due to Potential Material Oxidation

Howmedica Osteonics Corp. is recalling certain knee replacement devices (product number 6637-0-931, lot 57403601) because raw material used in manufacturing may be over 5 years old, potentially causing elevated oxidation that affects device durability.

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: This is a Class II device recall with no reported hospitalizations, injuries, or adverse events. The hazard—elevated oxidation in aged raw material that could affect device properties—is significant but theoretical, meeting the criterion for high-risk products where injury has not yet been reported.

Plain-English summary

Howmedica Osteonics Corp. is recalling certain RGT LARGE-PCA MOD.REV.- DUR.REV.INSERT knee replacement devices with product number 6637-0-931 and lot number 57403601.

The recall was initiated because raw UHMWPE material used in manufacturing these devices was over 5 years of age. Oxidation in aged UHMWPE can impact the material's mechanical properties and affect the long-term performance of the implant.

These devices have been distributed nationwide in the United States and internationally to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, the United Kingdom, the Netherlands, Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain. Patients who received these devices should contact their healthcare provider to determine if they may be affected.

If you have received one of these devices, consult your healthcare provider or Howmedica Osteonics Corp. to discuss whether your implant is part of this recall and what follow-up care, if any, may be warranted.

The recalled product

Product: RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-931
Manufacturer: Howmedica Osteonics Corp.
Category: Medical Device — Orthopedic Joint Replacement
Hazard: oxidation
material-degradation

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)

GTIN: 04546540306470 Lot Numbers: 57403601

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 58 recalled by Howmedica Osteonics Corp. 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 58 products in this recall →

Same manufacturer · Howmedica Osteonics Corp.

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Same hazard · oxidation