The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0907-2024·Announced 2024-02-07

Knee replacement inserts recalled for potential material oxidation

Howmedica Osteonics Corp. is recalling LEFT LARGE-PCA knee replacement inserts manufactured with raw material over 5 years old due to potential elevated oxidation levels that could affect material properties.

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: FDA Class II recall with no reported illnesses or device failures. The hazard—oxidation of UHMWPE material potentially degrading physical properties—represents a risk-of-harm scenario for a high-consequence orthopedic implant device, meeting the rubric criterion for High severity when injury has not yet been reported.

Plain-English summary

Howmedica Osteonics Corp. is recalling LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT knee replacement inserts (Part Number 6637-0-228) manufactured using ultra-high molecular weight polyethylene (UHMWPE) raw material that is over 5 years of age. The older raw material has the potential for elevated levels of oxidation, which could impact the mechanical properties of the insert.

This recall affects devices 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, and additional countries. As of January 25, 2024, the recall was expanded to include distribution to Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain. The affected lot number is 54537601.

No illnesses or injuries have been reported to date. Patients who have received this implant should consult with their orthopedic surgeon regarding their individual clinical circumstances. Healthcare providers should review their implant records to identify affected devices and determine whether patient follow-up evaluation is warranted.

The recalled product

Product
LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-228
Manufacturer
Howmedica Osteonics Corp.
Category
Medical Device — Orthopedic / Knee Replacement
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 (1)

  • GTIN: 04546540306012 Lot Numbers: 54537601

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 →

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